Product Code: KNT FDA class 2 21 CFR 876.5980

Tubes, Gastrointestinal (And Accessories)

Gastroenterology, Urology

Gastrointestinal Tubes and Accessories are devices inserted through the mouth, nose, or stoma into the gastrointestinal tract for purposes including enteral feeding, gastric drainage, decompression, and medication delivery in patients unable to take nutrition or medications orally. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KNT and the applicable regulation is 21 CFR 876.5980 in the Gastroenterology and Urology specialty.

View on FDA

510(k)s

649

FEI Numbers

242

Registration Numbers

243

Unique Applicants

293

Years Active

Basic Information

Product Code: KNT
Device Class: FDA class 2
Regulation Number: 876.5980
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 649 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250389	XNY Disposable Gastric Calibration Tube	Apr 10, 2025	Substantially Equivalent	Changzhou Xin Neng Yuan Medical Stapler Co., Ltd.
K243228	Flexi-Seal AIR (with ENFit Connector)	Mar 28, 2025	Substantially Equivalent	Convatec
K242336	hygh-tec Drainage II	Jan 17, 2025	Substantially Equivalent	AMB Medtec
K242901	ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)	Jan 10, 2025	Substantially Equivalent	Tools for Surgery, LLC
K241169	Entarik NI Feeding Tube System	Nov 22, 2024	Substantially Equivalent	Gravitas Medical, Inc.
K241185	CORGRIP* SR NG/NI Tube Retention System	Oct 25, 2024	Substantially Equivalent	Avanos Medical, Inc.
K240965	CORTRAK* 2 Enteral Access System (20-0950)	Jun 06, 2024	Substantially Equivalent	Avanos Medical, Inc.
K233591	Stylus	May 31, 2024	Substantially Equivalent	Degania Silicone Ltd.
K241039	ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)	May 16, 2024	Substantially Equivalent	ReShape Lifesciences
K234033	ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)	May 06, 2024	Substantially Equivalent	Boehringer Laboratories LLC
K240039	Enteral Feeding Sets	Apr 17, 2024	Substantially Equivalent	Hangzhou Primecare Medical Co., Ltd.
K240069	Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)	Feb 08, 2024	Substantially Equivalent	Endolumik
K234145	ViSiGi 3D Gastric Sizing Tube	Jan 26, 2024	Substantially Equivalent	Boehringer Laboratories
K222846	AMT G-Tube Balloon Gastrostomy Feeding Device	Dec 18, 2023	Substantially Equivalent	Applied Medical Technology, Inc.
K230206	Entarik Feeding Tube System; Entarik Feeding Tube	Mar 24, 2023	Substantially Equivalent	Gravitas Medical, Inc.
K222880	Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)	Mar 03, 2023	Substantially Equivalent	Endolumik Inc.
K230131	ReShape Calibration Tubes	Feb 15, 2023	Substantially Equivalent	ReShape Lifesciences
K221400	hygh-tec drainage	Feb 09, 2023	Substantially Equivalent	Creative Balloons GmbH
K222085	Standard Tapered Bougie, 38 Fr.	Oct 31, 2022	Substantially Equivalent	Standard Bariatrics, Inc.
K212316	DoubleChek DC-1001	Sep 30, 2022	Substantially Equivalent	Nasogastric Feeding Solutions, Ltd.
K221898	Gastrointestinal Boundary Identifier (GIBI HD)	Jul 28, 2022	Substantially Equivalent	ReShape Lifesciences
K212407	Gastric Lightguide (GLG)	Jul 26, 2022	Substantially Equivalent	Naser Dib Gabinet Lekarksi Nasmed
K220455	Lap-Band System Calibration Tube	Jun 07, 2022	Substantially Equivalent	ReShape Lifesciences
K220218	Siren SGT	May 18, 2022	Substantially Equivalent	Tools for Surgery, LLC
K220588	Avanos* CORTRAK* 2 Enteral Access System (EAS)	Apr 22, 2022	Substantially Equivalent	Avanos Medical Inc
K212444	Qora Stool Management Kit	Nov 17, 2021	Substantially Equivalent	CM Technologies, Inc.
K212728	Standard Bougie, 38 Fr. and Hand Pump	Sep 23, 2021	Substantially Equivalent	Standard Bariatrics
K210437	Standard Bougie, 38 Fr.	Jun 29, 2021	Substantially Equivalent	Standard Bariatrics
K211072	Safety Trocar Cannula	Apr 27, 2021	Substantially Equivalent	Boston Scientific Corporation
K202748	Enteral Feeding Catheter	Apr 09, 2021	Substantially Equivalent	Medcaptain Life Science Co., Ltd.
K203133	ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube	Mar 24, 2021	Substantially Equivalent	ENvizion Medical Ltd.
K200646	TubeClear System	Dec 04, 2020	Substantially Equivalent	Actuated Medical, Inc.
K202539	Nutriglide(TM) Nasal Feeding Tube	Oct 29, 2020	Substantially Equivalent	Applied Medical Technology, Inc.
K201322	Entuit Nasal Jejunal Feeding Tube	Jun 17, 2020	Unknown	Wilson-Cook Medical, Inc
K191885	Standard Bougie	Apr 08, 2020	Substantially Equivalent	Standard Bariatrics
K193325	Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches	Mar 13, 2020	Substantially Equivalent	ProSys International Ltd
K190977	Navina Smart System, Navina Classic System	Nov 22, 2019	Substantially Equivalent	Dentsply Sirona
K190084	McLean-Ring Enteral Feeding Tube Set	Oct 11, 2019	Substantially Equivalent	Cook Incorporated
K191387	ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube	Jun 14, 2019	Substantially Equivalent	Envizion Medical Ltd.
K191340	CORTRAK* 2 Equilateral Enteral Access System	Jun 04, 2019	Substantially Equivalent	Avanos Medical, Inc.
K183336	Entuit PEG, Entuit PEGJ	May 29, 2019	Unknown	Wilson-Cook Medical, Inc
K183577	Medline Quick-Clear Wand	May 04, 2019	Substantially Equivalent	Medline Industries, Inc.
K190114	Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)	Apr 30, 2019	Substantially Equivalent	ConvaTec Limited
K183508	Micro Transgastric-Jejunal Feeding Device	Mar 29, 2019	Unknown	Applied Medical Technology, Inc.
K182804	Traditional Length GJ Feeding Device	Mar 01, 2019	Substantially Equivalent	Applied Medical Technology, Inc.
K182915	ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube	Feb 13, 2019	Substantially Equivalent	ENvizion Medical Ltd.
K182248	Aspire Venting Tube	Nov 13, 2018	Substantially Equivalent	Aspire Bariatrics, Inc
K180605	GastroFlush	Oct 24, 2018	Substantially Equivalent	Bionix Development Corporation
K180622	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	Oct 23, 2018	Substantially Equivalent	Covidien
K180725	Aspire Introducer Needle	Jul 11, 2018	Substantially Equivalent	Aspire Bariatrics, Inc.
K172556	TubeClear System	Jun 29, 2018	Substantially Equivalent	Actuated Medical, Inc.
K180026	Bowel Management Device, Bowel Management Irrigation Set	Jun 01, 2018	Unknown	Applied Medical Technology, Inc.
K173955	Mic-Key* SF Over-the-Wire Stoma Measuring Device	Jan 26, 2018	Unknown	Halyard Health, Inc.
K173355	Gastric Sizing Balloon Catheter	Nov 17, 2017	Unknown	Cook Incorporated
K162340	Stomach Tube	Oct 11, 2017	Substantially Equivalent	WELL LEAD MEDICAL CO., LTD
K170319	Low Profile Non-Balloon Feeding Device	Oct 06, 2017	Substantially Equivalent	APPLIED MEDICAL TECHNOLOGY INC.
K170487	Navina Classic System	Sep 11, 2017	Substantially Equivalent	Dentsply Sirona
K160567	Barone Jejunostomy Catheter Set	May 18, 2017	Substantially Equivalent	COOK INCORPORATED
K160509	Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube	May 18, 2017	Unknown	COOK INCORPORATED
K163002	Kangaroo Feeding Tube with IRIS Technology	May 16, 2017	Substantially Equivalent	Covidien (dba Medtronic)
K162906	Flexi-Seal PROTECT Fecal Management System	Mar 07, 2017	Substantially Equivalent	ConvaTec
K161413	Low Profile Balloon Feeding Device	Feb 09, 2017	Substantially Equivalent	APPLIED MEDICAL TECHNOLOGY, INC.
K163092	TubeClear Control Box and Clearing Stem	Nov 30, 2016	Substantially Equivalent	Actuated Medical, Inc.
K162110	CORGRIP NG/NI Tube Retention System	Sep 15, 2016	Unknown	CORPAK MedSystems, Inc. a Division of Haylard Health
K160787	Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet	Aug 09, 2016	Unknown	SYNCRO MEDICAL INNOVATIONS, INC.
K152246	Aquarius Stoma Measuring Device	Jun 21, 2016	Substantially Equivalent	DEGANIA SILICONE LTD
K153506	Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit	May 06, 2016	Substantially Equivalent	CONSURE MEDICAL PVT LTD.
K160654	GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)	May 04, 2016	Substantially Equivalent	Covidien LLC
K153461	Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm	Dec 11, 2015	Substantially Equivalent	MAQUET CRITICAL CARE AB
K140310	Peristeen Anal Irrigation System	Sep 03, 2015	Substantially Equivalent	COLOPLAST A/S
K150350	Flexi-Seal Signal Fecal Management System	Jul 21, 2015	Substantially Equivalent	ConvaTec Ltd.
K142548	MIDSLEEVE	Jun 23, 2015	Substantially Equivalent	MEDICAL INNOVATION DEVELOPMENT
K142327	smARTrack Feeding Tube System	Jun 08, 2015	Substantially Equivalent	ART Healthcare Ltd.
K142971	AMT Bridle - Nasal Tube Retention System	May 26, 2015	Substantially Equivalent	Applied Medical Technology, Inc.
K143088	GastriSail Gastric Positioning System	Feb 25, 2015	Substantially Equivalent	COVIDIEN
K142816	AbbVie J	Jan 14, 2015	Substantially Equivalent	ABBVIE INC.
K142793	AbbVie PEG	Jan 14, 2015	Unknown	AbbVie Inc.
K142792	AbbVie NJ	Jan 14, 2015	Unknown	ABBVIE INC.
K143378	AQUARIUS Gastrostomy Replacement Tube	Dec 29, 2014	Substantially Equivalent	DEGANIA SILICONE LTD
K133334	VERITRACT ENTERAL FEEDING TUBE SYSTEM	Aug 26, 2014	Substantially Equivalent	VERITRACT, INC.
K141631	AQUARIUS EXTENSION FEEDING SET	Jul 28, 2014	Unknown	DEGANIA SILICONE, LTD.
K133077	GENERICA MEDICAL ENTERNAL DELIVERY; PUMP BAG SET, PUMP SPIKE SET, GRAVITY BAG SET	Jul 28, 2014	Substantially Equivalent	GENERICA MEDICAL INTERNATIONAL, INC.
K133465	CONSURE STOOL MANAGEMENT SYSTEM	Jun 26, 2014	Substantially Equivalent	CONSURE MEDICAL PVT LTD.
K133129	ABBVIE NJ	Jun 19, 2014	Substantially Equivalent	ABBVIE INC.
K133087	ABBVIE PEG	Jun 19, 2014	Substantially Equivalent	ABBVIE INC.
K133096	ABB VIE J	Jun 18, 2014	Substantially Equivalent	ABBVIE INC.
K131183	MED-RX ORAL/ENTERAL SYRINGE	Jun 03, 2014	Substantially Equivalent	BENLAN, INC.
K132686	AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE	May 12, 2014	Unknown	DEGANIA SILICONE, LTD.
K133251	BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM	May 09, 2014	Unknown	C.R. BARD, INC.
K123555	KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY	Apr 09, 2014	Substantially Equivalent	COVIDIEN
K133599	CORGRIP	Mar 26, 2014	Substantially Equivalent	CORPAK MEDSYSTEMS
K132424	METRIXCARE	Feb 12, 2014	Substantially Equivalent	THE METRIX COMPANY
K133881	MACY CATHETER	Jan 24, 2014	Substantially Equivalent	HOSPI CORPORATION
K130674	ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE	Jan 13, 2014	Substantially Equivalent	XERIDIEM MEDICAL DEVICES
K130611	ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE	Dec 19, 2013	Substantially Equivalent	XERIDIEM MEDICAL DEVICES
K131052	TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)	Aug 16, 2013	Substantially Equivalent	ACTUATED MEDICAL, INC.
K131532	ELECTROMAGNETIC TRANSMITTING STYLET	Aug 12, 2013	Substantially Equivalent	CORPAK MEDSYSTEMS
K122653	MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES	Jun 26, 2013	Unknown	KIMBERLY-CLARK CORPORATION
K123716	AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT	Apr 19, 2013	Unknown	APPLIED MEDICAL TECHNOLOGY, INC.
K123804	INSTAFLO BOWEL CATHETER SYSTEM KIT	Apr 17, 2013	Substantially Equivalent	HOLLISTER, INC.
K130483	BOEHRINGER GASTRIC SIZING TUBE	Mar 28, 2013	Substantially Equivalent	BOEHRINGER LABORATORIES, LLC
K123659	TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR)	Dec 20, 2012	Substantially Equivalent	ACTUATED MEDICAL, INC.
K122030	LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON	Sep 05, 2012	Substantially Equivalent	DEGANIA SILICONE, LTD.
K121571	TUBECLEAR	Jun 13, 2012	Substantially Equivalent	ACTUATED MEDICAL, INC
K112860	PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER	Jun 08, 2012	Substantially Equivalent	COLOPLAST A/S
K112511	DOBBHOFF DUAL PORT FEEDING TUBE	May 11, 2012	Substantially Equivalent	COVIDIEN LP, FORMERLY REGISTERED AS KENDALL
K112342	FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM	Apr 26, 2012	Substantially Equivalent	CONVATEC INC
K113719	SAFETY SCREW CONNECTOR	Apr 20, 2012	Substantially Equivalent	ABBOTT LABORATORIES
K120182	NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES	Apr 19, 2012	Substantially Equivalent	NEOMED, INC.
K112863	ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, ENTERAL EXTENSION SET WITH MINITUBE CONN	Mar 29, 2012	Substantially Equivalent	ACTA MEDICAL L.L.C.
K112268	CODAN SAFEFEED ENTERAL FEEDING RESERVOIR	Mar 19, 2012	Substantially Equivalent	CODAN US CORP.
K120272	AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET	Feb 17, 2012	Substantially Equivalent	KENTEC MEDICAL, INC.
K113351	CORTRAK ENTERAL ACCESS DEVICE	Jan 10, 2012	Substantially Equivalent	CORPAK MEDSYSTEMS
K102712	MED GRAVITY SET, IMED PUMP SET	Dec 16, 2011	Substantially Equivalent	IMED TECHNOLOGY, INC.
K102741	ENTERAL FEEDING BAG AND SETS	Nov 08, 2011	Substantially Equivalent	SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.
K110804	AMT G-J TUBE	Oct 19, 2011	Unknown	APPLIED MEDICAL TECHNOLOGY, INC.
K112434	BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION	Sep 29, 2011	Substantially Equivalent	BD MEDICAL SURGICAL
K110005	SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE	Aug 04, 2011	Unknown	SYNCRO MEDICAL INNOVATIONS, INC.
K110529	ENDOFLIP GASTRIC TUBE	Jul 22, 2011	Substantially Equivalent	CROSPON, LTD.
K103254	PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE	Jan 31, 2011	Substantially Equivalent	COLOPLAST A/S
K102572	IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT	Dec 27, 2010	Substantially Equivalent	SAINATH INTELLECTUAL PROPERTIES, LLC
K103109	PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE	Dec 22, 2010	Substantially Equivalent	C.R. BARD INC
K102391	BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM	Dec 22, 2010	Unknown	C.R. BARD, INC.
K102548	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	Nov 26, 2010	Substantially Equivalent	FOOTPRINT MEDICAL INC.
K101199	GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER,	Aug 27, 2010	Substantially Equivalent	MAQUET CRITICAL CARE AB
K100288	NEOMED ENTERAL ONLY EXTENSION SET	Aug 03, 2010	Substantially Equivalent	NEOMED, INC.
K100366	MEDICINA ENTERAL FEEDING TUBES AND ACCESSORIES MODEL MGX/YY	Jun 14, 2010	Substantially Equivalent	MAXTER CATHETERS
K100365	FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV	May 20, 2010	Substantially Equivalent	CORPAK MEDSYSTEMS
K092628	ENTERAL FEEDING TUBE AND ACCESSORIES, FEEDING TUBE EXTENSION SET	May 20, 2010	Substantially Equivalent	ALAN REID
K100273	INSTAFLO BOWEL CATHETER SYSTEM KIT	Apr 22, 2010	Unknown	HOLLISTER, INC.
K100173	IYUNNI 3ID TRI-FUNNEL FEEDING TUBE KIT	Apr 16, 2010	Unknown	SAINATH INTELLECTUAL PROPERTIES, LLC
K093653	URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK	Feb 23, 2010	Unknown	URESIL, LLC
K083770	COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM	Nov 23, 2009	Substantially Equivalent	COLOPLAST A/S
K092418	ENTRACARE GASTROSTOMY FEEDING TUBE	Oct 23, 2009	Substantially Equivalent	ENTRACARE, LLC
K092049	IYUNNI 3ID TRI-FUNNEL GASTROSTOMY TUBE KIT	Oct 09, 2009	Unknown	SAINATH INTELLECTUAL PROPERTIES, LLC
K091637	CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900	Sep 29, 2009	Substantially Equivalent	CORPAK MEDSYSTEMS
K091759	SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H	Sep 18, 2009	Substantially Equivalent	OLYMPUS MEDICAL SYSTEMS CORPORATION
K083685	ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285	Jun 25, 2009	Substantially Equivalent	MRI MANUFACTURING AND RESEARCH, INC.
K090559	FOOTPRINT MEDICAL SILICONE FEEDING TUBE	May 04, 2009	Substantially Equivalent	FOOTPRINT MEDICAL
K083684	ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX	Feb 05, 2009	Substantially Equivalent	MANUFACTURING & RESEARCH, INC.
K083153	ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007	Feb 04, 2009	Unknown	HOLLISTER, INC.
K082710	SAFECHILD ENTERAL FEEDING TUBE AND ACCESSORIES AND FEEDING TUBE EXTENSION SET	Jan 23, 2009	Substantially Equivalent	NEOCHILD, LLC
K082863	DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML)	Jan 09, 2009	Substantially Equivalent	DYNAREX CORPORATION
K081739	2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT	Dec 03, 2008	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K082654	ENTERAL ONLY EXTENSION SET	Nov 25, 2008	Substantially Equivalent	RESPIRONICS, INC.
K081725	ENTERAL PUMP SET, MODEL 20-1010	Nov 07, 2008	Substantially Equivalent	VIASYS MEDSYSTEMS
K082241	THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751	Oct 30, 2008	Substantially Equivalent	DALE MEDICAL PRODUCTS, INC.
K080679	MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900	Jun 27, 2008	Substantially Equivalent	VIASYS MEDSYSTEMS
K073598	BARD DIGNICARE STOOL MANAGEMENT SYSTEM	Jun 13, 2008	Unknown	C.R. BARD, INC.
K080328	MPS ACACIA ENTERAL FEEDING TUBE	May 14, 2008	Substantially Equivalent	MPS ACACIA
K073034	AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)	Mar 14, 2008	Unknown	APPLIED MEDICAL TECHNOLOGY, INC.
K080340	COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG	Mar 05, 2008	Substantially Equivalent	NOVARTIS NUTRITION CORP.
K072652	ENTERAL FEEDING SPIKE ADAPTER	Jan 18, 2008	Substantially Equivalent	CEDIC S.R.L.
K072756	NON-IV ADAPTER FOR INFANT NG TUBE	Dec 19, 2007	Unknown	PROMEDIC, INC.
K072476	THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT	Dec 14, 2007	Unknown	Boston Scientific Corporation
K072550	SIGHTSURE OPERATIONAL INDICATOR, MODEL SS301	Dec 07, 2007	Substantially Equivalent	MEDEVICE, INC.
K071579	PEF TUBE	Nov 20, 2007	Substantially Equivalent	N.M. BEALE CO. INC.
K072787	GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111	Oct 31, 2007	Substantially Equivalent	SYNCRO MEDICAL INNOVATIONS, INC.
K071764	REALIZE GASTRIC CALIBRATION TUBE, MODELS GCT180, GCT360	Oct 24, 2007	Substantially Equivalent	OBTECH MEDICAL SARL
K070449	LUMILOC (TM) SAFETY INTRODUCER NEEDLE	Jun 14, 2007	Substantially Equivalent	SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC.
K070124	GASTROSTOMY REPLACEMENT TUBE, MODEL 253	May 23, 2007	Substantially Equivalent	DEGANIA SILICONE, LTD.
K063061	CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900	Apr 02, 2007	Substantially Equivalent	VIASYS MEDSYSTEMS
K063118	BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE	Feb 13, 2007	Substantially Equivalent	C.R. BARD, INC.
K061432	HOSPIRA ENTERAL FEEDING SET, MODEL 20640	Sep 11, 2006	Substantially Equivalent	HOSPIRA, INC.
K061021	ENTAKE STANDARD AND SAFETY PEG SYSTEM	Apr 28, 2006	Substantially Equivalent	CONMED CORP.
K052903	PEDIATRIC FEEDING TUBE	Nov 09, 2005	Substantially Equivalent	PROMEDIC, INC.
K051206	Y2K2 ENTERNAL TUBE FLUID FILTER	Nov 02, 2005	Substantially Equivalent	MOSS MEDICAL PRODUCTS
K051551	SMALL INTESTINAL VIDEOSCOPE SYSTEM	Jun 28, 2005	Substantially Equivalent	OLYMPUS MEDICAL SYSTEMS CORPORATION
K042431	PROCON2	May 27, 2005	Substantially Equivalent	INCONTINENT CONTROL DEVICES, INC.
K043203	WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE	May 11, 2005	Substantially Equivalent	WILSON-COOK MEDICAL, INC.
K043044	ANTI-I.V. ENTERAL FEEDING SYSTEM	May 06, 2005	Substantially Equivalent	VIASYS MEDSYSTEMS
K042112	INFANT FEEDING TUBE	Jan 28, 2005	Substantially Equivalent	MARIAN MEDICAL, INC.
K041987	CORTRAK	Dec 17, 2004	Substantially Equivalent	VIASYS MEDSYSTEMS
K043258	MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-02	Dec 16, 2004	Substantially Equivalent	TELEFLEX MEDICAL
K043114	KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE	Dec 10, 2004	Substantially Equivalent	KIMBERLY-CLARK CORP.
K043027	MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20	Dec 02, 2004	Unknown	APPLIED MEDICAL TECHNOLOGY, INC.
K042572	KENDALL CO2NFIRM NOW CO2 DETECTOR	Nov 05, 2004	Substantially Equivalent	KENDALL
K042300	AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM	Oct 25, 2004	Substantially Equivalent	APPLIED MEDICAL TECHNOLOGY, INC.
K041034	SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL)	Aug 31, 2004	Substantially Equivalent	ENTRACARE, LLC
K030413	Y2K2 ENTERNAL FEEDING MANAGER	May 11, 2004	Substantially Equivalent	MOSS MEDICAL PRODUCTS
K032734	CONVATEC FECAL MANAGEMENT SYSTEM	Apr 08, 2004	Substantially Equivalent	CONVATEC, A BRISTOL-MYERS SQUIBB CO.
K030784	NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVAL	Apr 01, 2004	Substantially Equivalent	APPLIED MEDICAL TECHNOLOGY, INC.
K031492	MOSSMED DUAL INTERMITTENT ASPIRATOR	Feb 05, 2004	Substantially Equivalent	MOSS MEDICAL PRODUCTS
K033562	FASTRAC GASTRIC ACCESS PORT KIT	Dec 12, 2003	Substantially Equivalent	C.R. BARD, INC.
K030841	COOK GASTRIC SIZING BALLOON CATHETER	Jul 11, 2003	Substantially Equivalent	COOK, INC.
K022558	NGT	Jul 08, 2003	Substantially Equivalent	MEDICAL INNOVATIVE PRODUCTS
K031538	ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT	Jun 27, 2003	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K030855	MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT	Apr 17, 2003	Unknown	BOSTON SCIENTIFIC CORP.
K022112	FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020	Apr 03, 2003	Substantially Equivalent	FORTUNE MEDICAL INSTRUMENT CORP.
K023344	INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE	Nov 06, 2002	Substantially Equivalent	BOWEL MANAGEMENT SYSTEMS, LLC
K022648	ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521	Sep 05, 2002	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K021493	ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S	Aug 30, 2002	Substantially Equivalent	ANDERSEN PRODUCTS, INC.
K020120	ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220	Aug 02, 2002	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K021991	MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE	Jul 18, 2002	Substantially Equivalent	SYNCRO MEDICAL INNOVATIONS, INC.
K020005	INFANT FEEDING TUBES	Jul 16, 2002	Substantially Equivalent	PROMEDIC, INC.
K014297	ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT; ENDOVIVE LOW PROFILE BUTTON REPLACEMENT GASTROSTOMY TUBE; SECURI-T INITIAL P	Jul 09, 2002	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K021034	MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER	Jun 26, 2002	Substantially Equivalent	TFX MEDICAL, INC.
K020985	MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER	Jun 25, 2002	Substantially Equivalent	TFX MEDICAL, INC.
K020379	PPD BALLOON DILATATION CATHETER	May 06, 2002	Substantially Equivalent	TELEMED SYSTEMS, INC.
K012113	INDWELLING FECAL MANAGEMENT SYSTEM	May 03, 2002	Substantially Equivalent	BOWEL MANAGEMENT SYSTEMS, LLC
K010798	RUSCH CANTOR TUBE	Feb 26, 2002	Substantially Equivalent	RUSCH INTL.
K010797	RUSCH MILLER-ABBOTT TUBE	Feb 26, 2002	Substantially Equivalent	RUSCH INTL.
K012147	DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE	Nov 02, 2001	Substantially Equivalent	ZEVEX, INC.
K013162	14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH	Oct 19, 2001	Substantially Equivalent	MEDCOMP
K013144	DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE; DUAL PORT WIZARD FEEDING/DECOMPRESSION TUBE, MODEL 00220W	Oct 19, 2001	Substantially Equivalent	C.R. BARD, INC.
K011343	LH 500 ENTERAL FEEDING GRAVITY BAG SET	Sep 21, 2001	Substantially Equivalent	LH MEDICAL PRODUCTS, INC.
K011341	LH400 YES-SET Y-PORT ENTERAL SPIKE PUMP SET	Sep 21, 2001	Substantially Equivalent	LH MEDICAL PRODUCTS, INC.
K011340	LH 450 ENTERAL FEEDING BAG PUMP SET W/INTEGRATED Y-PORT	Sep 21, 2001	Substantially Equivalent	LH MEDICAL PRODUCTS, INC.
K012476	MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-2010	Aug 31, 2001	Substantially Equivalent	APPLIED MEDICAL TECHNOLOGY, INC.
K011467	ROSS EMBRACE PUMP SET	Aug 10, 2001	Substantially Equivalent	ROSS PRODUCTS
K002838	GASTRIC SUCTION AND DRAINAGE CATHETER	Jul 09, 2001	Substantially Equivalent	BIOENTERICS CORP.
K011077	ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22)	May 09, 2001	Substantially Equivalent	ANDERSEN PRODUCTS, INC.
K001916	COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX	Feb 16, 2001	Substantially Equivalent	NOVARTIS NUTRITION CORP.
K990365	GASTRIC LAVAGE VALVE	Jul 26, 2000	Substantially Equivalent	T-MED VAC CORPORATION
K993358	SIGHTSURE OPERATION INDICATOR, MODEL SS301	Mar 15, 2000	Substantially Equivalent	MEDEVICES, INC.
K994300	NASOGASTRIC TUBE HOLDER, MODEL 160	Feb 10, 2000	Substantially Equivalent	DALE MEDICAL PRODUCTS, INC.
K992719	AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE	Jan 12, 2000	Substantially Equivalent	AMSINO INTL., INC.
K993296	TRIP TONOMETRY CATHETER, 14F	Dec 15, 1999	Substantially Equivalent	DATEX-OHMEDA, INC.
K991918	NUTRISAFE EXTENSION TUBE	Oct 29, 1999	Substantially Equivalent	VYGON CORP.
K993138	BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT	Oct 20, 1999	Substantially Equivalent	BALLARD MEDICAL PRODUCTS
K991375	BARD BALLOON INFLATION SYSTEM	Sep 10, 1999	Substantially Equivalent	C.R. BARD, INC.
K992494	FLEXIFLO ENTERAL FEEDING TUBE	Aug 25, 1999	Substantially Equivalent	ROSS PRODUCT DIV. ABBOTT LABORATORIES
K992181	TRIP TONOMETRY CATHETER, 8F	Aug 24, 1999	Substantially Equivalent	DATEX-OHMEDA, INC.
K991668	COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12)	Jul 26, 1999	Substantially Equivalent	NOVARTIS NUTRITION CORP.
K990863	MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE	Apr 06, 1999	Substantially Equivalent	ROSS PRODUCT DIV. ABBOTT LABORATORIES
K990389	MOSS GASTROSTOMY TUBE	Mar 22, 1999	Substantially Equivalent	MOSS TUBES, INC.
K984628	MODIFICATION OF MOSS P.E.G. TRAY	Mar 17, 1999	Substantially Equivalent	MOSS TUBES, INC.
K983476	BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES	Mar 01, 1999	Substantially Equivalent	NAVION BIOMEDICAL CORP.
K984310	MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE	Feb 24, 1999	Substantially Equivalent	MOSS TUBES, INC.
K990127	CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE (LPGD)	Feb 10, 1999	Substantially Equivalent	CORPAK MEDSYSTEMS
K982500	CHAIT CECOSTOMY CATHETER	Jan 27, 1999	Substantially Equivalent	COOK, INC.
K983366	TRIP TONOMETRY CATHETER, 16F	Dec 23, 1998	Substantially Equivalent	DATEX-ENGSTROM, INC.
K981323	COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE	Oct 09, 1998	Substantially Equivalent	NOVARTIS NUTRITION CORP.
K982894	MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT	Sep 11, 1998	Substantially Equivalent	BALLARD MEDICAL PRODUCTS
K971434	A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE	Aug 17, 1998	Substantially Equivalent	APPLIED MEDICAL TECHNOLOGIES
K981203	RUSCH BLAKEMORE 3 LUMEN, STERILE	Jun 05, 1998	Substantially Equivalent	RUSCH INTL.
K973892	RUSCH BLAKEMORE TUBE - 4 LUMEN (MINNESOTA TYPE)	May 18, 1998	Substantially Equivalent	RUSCH INTL.
K980305	AMT BUTTON REPLACEMENT GASTROSTOMY DEVICE	Apr 16, 1998	Substantially Equivalent	APPLIED MEDICAL TECHNOLOGY, INC.
K974806	VYGON NEO-SUMP	Mar 23, 1998	Substantially Equivalent	VYGON CORP.
K973409	KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS	Feb 27, 1998	Substantially Equivalent	DAVIS & GECK, INC.
K972478	PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES	Feb 09, 1998	Substantially Equivalent	APPLIED MEDICAL TECHNOLOGIES
K972102	RADIUS PUSH OVER THE GUIDE WIRE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT	Jan 23, 1998	Substantially Equivalent	RADIUS INTL., INC.
K972025	RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT	Jan 23, 1998	Substantially Equivalent	RADIUS INTL., INC.
K971901	RADIUS LOW PROFILE GASTROSTOMY TUBE KIT	Jan 22, 1998	Substantially Equivalent	RADIUS INTL., INC.
K973891	LAPAROSCOPIC GASTROSTOMY KIT	Jan 12, 1998	Substantially Equivalent	APPLIED MEDICAL RESOURCES
K973893	AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE	Dec 19, 1997	Substantially Equivalent	APPLIED MEDICAL TECHNOLOGIES
K971757	LOW PROFILE FEEDING SET ACCESSORY	Nov 07, 1997	Substantially Equivalent	APPLIED MEDICAL TECHNOLOGIES
K962554	FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE	Nov 07, 1997	Substantially Equivalent	ABBOTT LABORATORIES
K970849	ENTERAL NUTRITION 1000 ML/500ML	Aug 15, 1997	Substantially Equivalent	MEDICAL INFUSION TECHNOLOGIES, INC.
K970178	CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM	Jul 21, 1997	Substantially Equivalent	CORPAK, INC.
K964920	RPI DUAL PORT IRRIGATION ADAPTER	Jul 09, 1997	Substantially Equivalent	RIDGE PRODUCTS, INC.
K971230	SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT	Jun 13, 1997	Substantially Equivalent	INNERDYNE, INC.
K970890	#ES-32 SUCTION CATHETER 32 FR.	May 23, 1997	Substantially Equivalent	TRI-MED SPECIALTIES, INC.
K965087	COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000)	Mar 18, 1997	Unknown	SANDOZ NUTRITION
K950017	FLEXIFLO FLOCATOR SMALL BOWEL FEEDING SYSTEM	Mar 14, 1997	Substantially Equivalent	ROSS PRODUCTS
K961664	COMPAT NASOJEJUNAL FEEDING TUBE	Oct 04, 1996	Substantially Equivalent	SANDOZ NUTRITION
K963113	FLEXIFLO POLYG GASTOSTOMY TUBE	Oct 02, 1996	Substantially Equivalent	ABBOTT LABORATORIES
K961345	DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE	Sep 17, 1996	Substantially Equivalent	APPLIED MEDICAL TECHNOLOGIES
K962375	MICROVASIVE BALLOON GASTROSTOMY TUBE KIT	Sep 04, 1996	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K935512	CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE	Aug 29, 1996	Substantially Equivalent	CORPAK CO.
K961884	CATH CADDIE	Aug 01, 1996	Substantially Equivalent	MARK-CLARK
K955181	U.S. ENDOSCOPY GROUP, INC. BALLOON REPLACEMENT GASTROSTOMY TUBE	Jun 05, 1996	Substantially Equivalent	UNITED STATES ENDOSCOPY GROUP, INC.
K955248	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	May 21, 1996	Unknown	UNITED STATES ENDOSCOPY GROUP, INC.
K960677	KANGAROO JEJUNAL FEEDING SYSTEM	May 13, 1996	Substantially Equivalent	SHERWOOD MEDICAL CO.
K960632	KANGAROO FEEDING TUBE PLACMENT STYLET	May 09, 1996	Substantially Equivalent	SHERWOOD MEDICAL CO.
K960415	WILSON-COOK BALLOON INFLATION DEVICE	Apr 26, 1996	Substantially Equivalent	WILSON-COOK MEDICAL, INC.
K960177	P.E.G. PATIENT CARE KIT	Mar 29, 1996	Substantially Equivalent	UNITED STATES ENDOSCOPY GROUP, INC.
K954879	PERCUTANEOUS REPLACEMENT GASTROSTOMY FEEDING CATHETER TRAY (MODIFICATION)	Mar 29, 1996	Substantially Equivalent	UNITED STATES ENDOSCOPY GROUP, INC.
K954429	KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT	Mar 08, 1996	Unknown	SHERWOOD MEDICAL CO.
K954776	REPLACEMENT GASTROSTOMY FEEDING CATHETER TRAY	Jan 22, 1996	Substantially Equivalent	UNITED STATES ENDOSCOPY GROUP, INC.
K946249	BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBES	Dec 11, 1995	Substantially Equivalent	C.R. BARD, INC.
K922567	LOW PROFILE CATHETER	Nov 21, 1995	Unknown	RUSCH, INC.
K945618	GASTROINTESTINAL TUBES & ACCESSORIES	Oct 12, 1995	Substantially Equivalent	APPLIED MEDICAL TECHNOLOGIES
K941228	ENDOLUMINAL ACCESS TUBE	Sep 27, 1995	Unknown	MED INSTITUTE, INC.
K953375	NG SECURE	Sep 08, 1995	Substantially Equivalent	M.C. JOHNSON CO., INC.
K946140	PRG BUTTON	Aug 28, 1995	Substantially Equivalent	APPLIED MEDICAL TECHNOLOGIES
K953232	HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICE	Aug 18, 1995	Substantially Equivalent	HOLLISTER, INC.
K923488	GASTRANIMAL PERCUTANEOUS REPLACEMENT GASTROOMY	Jul 20, 1995	Substantially Equivalent	APPLIED MEDICAL TECHNOLOGIES
K931921	CORPAK GASTROSTOMY TUBE	Jun 09, 1995	Substantially Equivalent	CORPAK CO.
K951489	MRI'S ALL SILICONE GASTROSTOMY TUBE	Jun 07, 1995	Substantially Equivalent	MANUFACTURING & RESEARCH, INC.
K932880	GRASSI GASTROJEJUNOSTOMY TUBE	Jun 07, 1995	Substantially Equivalent	BISSELL MEDICAL PRODUCTS, INC.
K924306	PERCUTANEOUS ENDOSCOPIC GASTROSTOMY	May 15, 1995	Substantially Equivalent	UNITED STATES ENDOSCOPY GROUP, INC.
K945612	MIC NASOGASTRIC-GASTROJEJUNAL FEEDING TUBE	Apr 19, 1995	Substantially Equivalent	MEDICAL INNOVATIONS CORP.
K943240	FLEXIFLO SIX ENTERAL NUTRITION PUMP SET	Apr 13, 1995	Substantially Equivalent	ABBOTT LABORATORIES
K922217	FLEXIFLO NASOENTERIC FEEDING TUBE	Mar 01, 1995	Substantially Equivalent	ABBOTT LABORATORIES
K945012	CATCO NUTRITIONAL CATHETER	Feb 24, 1995	Substantially Equivalent	CATCO MEDICAL, INC.
K940548	MIC PERCUTANEOUS ENDOSCOPIC JEJUNAL FEEDING TUBE	Feb 22, 1995	Substantially Equivalent	MEDICAL INNOVATIONS CORP.
K921478	GUARDPORT	Jan 11, 1995	Substantially Equivalent	HEALTH IMPROVEMENT ASSOC.
K922216	FLEXIFLO TUBE PLACEMENT VERIFIER	Jan 09, 1995	Substantially Equivalent	ABBOTT LABORATORIES
K943675	ENTERAL DELIVERY SETS WITH HYDRATION PORT	Dec 30, 1994	Substantially Equivalent	CLINTEC TECHNOLOGIES, INC.
K924850	VANSONNENBERG GASTROSTOMY CATHETER	Dec 29, 1994	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K943685	MIC DISPOSABLE SNARE	Nov 01, 1994	Substantially Equivalent	MEDICAL INNOVATIONS CORP.
K935633	NO-MES	Sep 30, 1994	Substantially Equivalent	ETHOX CORP.
K923046	BIOLOGIC DT-1000 MACHINE	Sep 30, 1994	Substantially Equivalent	HEMOCLEANSE, INC.
K933842	KLEIN RECTAL TAMPNADE BALLOON	Sep 29, 1994	Substantially Equivalent	COOK UROLOGICAL, INC.
K935198	GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS	Sep 28, 1994	Substantially Equivalent	LAKE REGION MFG., INC.
K926581	MIC TRANSGASTRIC JEJUNAL TUBE	Sep 28, 1994	Substantially Equivalent	MEDICAL INNOVATIONS CORP.
K932295	NON-BALLOON REPLACEMENT GASTROSTOMY KIT	Sep 08, 1994	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K935045	BIOSEARCH LAPROSCOPIC GASTRONOMY CATHETER	Aug 19, 1994	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K920579	LOW PROFILE PASSPORT PUSH & PULL KITS & PEG TUBE	Jul 08, 1994	Substantially Equivalent	WILSON-COOK MEDICAL, INC.
K923002	ENTEROCLYSIS TUBE	Jun 28, 1994	Unknown	BIOSEARCH MEDICAL PRODUCTS, INC.
K925061	HELLER TRANSILLUMINATING STYLETTE	Jun 27, 1994	Substantially Equivalent	DEVICE RESOURCES
K923168	DUAL PORT ENTERAL Y-ADAPTOR	Jun 17, 1994	Substantially Equivalent	ORION LIFE SYSTEMS, INC.
K932861	FLEXIFLO GASTROSTOMY KIT	Jun 09, 1994	Unknown	ABBOTT LABORATORIES
K925102	FLEXIFLO LAPAROSCOPIC JEJUNOSTOMY KIT	Jun 09, 1994	Unknown	ABBOTT LABORATORIES
K921680	E-Z PEG	May 06, 1994	Unknown	MILL-ROSE LABORATORY
K925854	VYGON - ENTERAL FEEDING TUBE - POLYURETHANE	May 02, 1994	Substantially Equivalent	VYGON CORP.
K921652	MIC TRANSGASTRIC JEJUNAL FEEDING TUBE KIT	May 02, 1994	Unknown	MEDICAL INNOVATIONS CORP.
K921370	MIC GASTRO-ENTEROSTOMY TUBE MODIFICATION	May 02, 1994	Unknown	MEDICAL INNOVATIONS CORP.
K936168	WILSON-COOK BALLOON INFLATION DEVICE	Mar 28, 1994	Substantially Equivalent	WILSON-COOK MEDICAL, INC.
K934772	GASTRONOMY TUBE HOLDER	Feb 28, 1994	Substantially Equivalent	NELMED CORP.
K925261	NUTRICARE ENTERAL FEEDING TUBE	Feb 17, 1994	Substantially Equivalent	ENTRACARE CORP.
K924065	MIC PEG TUBE	Feb 17, 1994	Unknown	MEDICAL INNOVATIONS CORP.
K922998	ENFUSE ENTERAL FEEDING TUBE	Dec 03, 1993	Substantially Equivalent	RUSCH, INC.
K920703	GASTROINTESTINAL FEEDING TUBE	Dec 03, 1993	Substantially Equivalent	WILSON-COOK MEDICAL, INC.
K922667	MIC LOW PROFILE GASTROSTOMY TUBE	Dec 01, 1993	Unknown	MEDICAL INNOVATIONS CORP.
K930456	INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR	Nov 17, 1993	Substantially Equivalent	INTERVENTIONAL THERAPEUTICS CORP.
K932855	HOLLISTER VERTICAL DRAIN/TUBE ATTACHMENT DEVICE	Oct 13, 1993	Substantially Equivalent	HOLLISTER, INC.
K924996	FLEXIFLO 60 NASOJEJUNAL FEEDING TUBE	Oct 08, 1993	Substantially Equivalent	ABBOTT LABORATORIES
K924697	FLEXIFLO LAPAROSCOPIC GASTROSTOMY KIT	Aug 27, 1993	Unknown	ABBOTT LABORATORIES
K924308	GASTROPORT II	Jul 29, 1993	Unknown	SANDOZ NUTRITION
K921853	4 SURE TM FEEDING TUBES	Jul 13, 1993	Substantially Equivalent	BOSTON PACIFIC MEDICAL, INC.
K915841	BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPIC	Jun 25, 1993	Unknown	C.R. BARD, INC.
K923692	STOMA MEASURING DEVICE	May 07, 1993	Unknown	APPLIED MEDICAL TECHNOLOGIES
K920262	ONAT BALLOONED NASOGASTRIC TUBE	Apr 20, 1993	Substantially Equivalent	MACDONALD MEDICAL DEVICES, INC.
K923983	PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KIT	Apr 06, 1993	Substantially Equivalent	SANDOZ NUTRITION
K915837	NON-BALLOON REPLACEMENT GASTROSTOMY SYSTEM	Mar 23, 1993	Unknown	C.R. BARD, INC.
K923474	LOW PROFILE GASTROMSTOMY DEVICE	Jan 05, 1993	Unknown	BIOSEARCH MEDICAL PRODUCTS, INC.
K921127	PANDA NEEDLE CATHETER JEJUNOSTOMY KIT	Jan 04, 1993	Unknown	KNIGHT MEDICAL, INC.
K920493	PEG PREP TRAY	Jan 04, 1993	Unknown	SANDOZ NUTRITION
K922209	NASOGRASTRIC TUBBE HOLDER	Oct 30, 1992	Substantially Equivalent	INNOVATIVE MEDICAL DESIGN CORP.
K921697	FLEXIFLO COMPANION ENTERAL PUMP SETS AND CONTAINER	Aug 25, 1992	Substantially Equivalent	ABBOTT LABORATORIES
K915735	FLEXIFLO QUANTUM ENT. PUMP SETS AND ENT. NUT. CONT	Jun 24, 1992	Substantially Equivalent	ABBOTT LABORATORIES
K920894	DECOMPRESSION TUBES	Apr 28, 1992	Substantially Equivalent	APPLIED MEDICAL TECHNOLOGIES
K921026	PRESSURE GAUGE	Apr 24, 1992	Substantially Equivalent	HOBBS MEDICAL, INC.
K915110	FLEXIFLO OVER-THE-GUIDEWIRE GASTROSTOMY KIT	Apr 14, 1992	Unknown	ABBOTT LABORATORIES
K914375	NON-WEIGHTED POLYURETHANE ENTERAL FEEDING TUBE	Mar 06, 1992	Substantially Equivalent	SHERWOOD MEDICAL CO.
K913997	SAECG CARDIOGRAPH MODEL M1754A	Mar 06, 1992	Substantially Equivalent	HEWLETT-PACKARD CO.
K913476	GI BLEEDER/OD SET	Feb 12, 1992	Unknown	ICU MEDICAL, INC.
K915171	LOPEZ VALVE TM II	Feb 07, 1992	Substantially Equivalent	ICU MEDICAL, INC.
K913784	DOBBHOFF(R) SINGLE PASS PEG KIT	Jan 15, 1992	Unknown	BIOSEARCH MEDICAL PRODUCTS, INC.
K913786	FLEXIFLO OVER-THE-GUIDEWIRE GAST KIT W/CR-BAR BUMP	Nov 05, 1991	Unknown	ABBOTT LABORATORIES
K900623	ZIMMON ESOPHAGO-GASTRIC BALLOON TAMPONADE DEVICE	Oct 07, 1991	Substantially Equivalent	WILSON-COOK MEDICAL, INC.
K913603	FIBRETWINS	Sep 30, 1991	Substantially Equivalent	ORAL-B LABORATORIES
K912047	WILSON-COOK RUSSELL GASTROSTOMY KIT	Sep 05, 1991	Substantially Equivalent	WILSON-COOK MEDICAL, INC.
K910382	FLEXIFLO ENTERAL FEEDING TUBE	Aug 07, 1991	Substantially Equivalent	ABBOTT LABORATORIES
K911897	GASPARAITIS ESOPHAGRAM CATHETER SET	Jul 24, 1991	Substantially Equivalent	E-Z-EM, INC.
K910910	MOSS- ANCHOR SET	Jun 24, 1991	Substantially Equivalent	MOSS MEDICAL PRODUCTS
K910912	MOSS NASAL TUBE MARK IV	May 28, 1991	Substantially Equivalent	MOSS MEDICAL PRODUCTS
K910911	MOSS P.E.G. TRAY	May 03, 1991	Substantially Equivalent	MOSS MEDICAL PRODUCTS
K910913	MOSS GASTROSTOMY TUBE	Apr 19, 1991	Substantially Equivalent	MOSS MEDICAL PRODUCTS
K910332	FLEXIFLO SACKS-VINE GASTROSTOMY KITS	Mar 19, 1991	Unknown	ABBOTT LABORATORIES
K905164	TUBE DECLOGGER	Feb 13, 1991	Substantially Equivalent	NOVA DESIGN TECHNOLOGIES, LTD.
K902623	FLEXIFLO STOMATE EXTENSION TUBE	Jan 31, 1991	Substantially Equivalent	ABBOTT LABORATORIES
K903662	PEEWEE REPLACEMENT GASTROSTOMY TUBE	Dec 12, 1990	Unknown	BIOSEARCH MEDICAL PRODUCTS, INC.
K900464	MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE	Dec 05, 1990	Unknown	MEDICAL INNOVATIONS CORP.
K903579	FLEXIFLO STOMATE DECOMPRESSION TUBE	Nov 27, 1990	Substantially Equivalent	ABBOTT LABORATORIES
K903325	FLEXIFLO (R) VERSA-PEG (TM) GASTROSTOMY KIT	Nov 19, 1990	Unknown	ABBOTT LABORATORIES
K902099	WILSON-COOK VARICES TAMPONADE BALLOON CUFF	Nov 07, 1990	Substantially Equivalent	WILSON-COOK MEDICAL, INC.
K895650	ENTERAL PUMP SET W/ENTERA-FLO SPIKE	Oct 02, 1990	Substantially Equivalent	DELMED, INC.
K895329	600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA	Oct 02, 1990	Substantially Equivalent	DELMED, INC.
K895142	ENTERAL PUMP SET WITH ENTERAL SPIKE	Oct 02, 1990	Substantially Equivalent	DELMED, INC.
K902641	RPI ENTERAL FEEDING BAG 1000ML AND 500ML	Oct 01, 1990	Substantially Equivalent	RIDGE PRODUCTS, INC.
K902684	MIC ANAL INCONTINENCE TUBE	Sep 12, 1990	Substantially Equivalent	MEDICAL INNOVATIONS CORP.
K901835	LAKE N/G FEEDING TUBE (WITH Y PORT CONNECTOR)	Sep 05, 1990	Substantially Equivalent	LAKE MEDICAL PRODUCTS, INC.
K902729	R.P.I. GRAVITY SAFE FEEDING BAG	Aug 08, 1990	Substantially Equivalent	RIDGE PRODUCTS, INC.
K900624	DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING SYSTEM	Aug 02, 1990	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K900590	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	Aug 02, 1990	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K900563	DOBBHOFF(R) ENDOENTERIC GASTRIC DECOMPRESSION CATH	Aug 02, 1990	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K900324	DOBBHOFF WIRE GUIDED JEJUNAL FEEDING TUBE	Aug 02, 1990	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K901023	GASTROINTESTINAL TUBES AND ACCESSORIES	Jul 02, 1990	Substantially Equivalent	MEDLINE INDUSTRIES, INC.
K901574	ACKRAD MPR DRAINAGE CATHETER SET	Jun 29, 1990	Substantially Equivalent	ACKRAD LABORATORIES
K901683	IMPROVED BAKER TWIN-CUFF SUMP TUBE	Jun 27, 1990	Substantially Equivalent	BISSELL MEDICAL PRODUCTS, INC.
K901134	ENTERA-FLO REPLACEMENT GASTROSTOMY TUBE	Jun 20, 1990	Unknown	FRESENIUS PHARMA
K901753	600 OR 1200 ML. ENTERAL BAG ADMINISTRATION SET	Jun 01, 1990	Substantially Equivalent	CHARTERMED, INC.
K901130	ENTERA-FLO FEEDING TUBE	Jun 01, 1990	Substantially Equivalent	FRESENIUS PHARMA
K900852	MAGNET RETRIEVAL CATHETER	May 02, 1990	Substantially Equivalent	COOK, INC.
K895933	ENTERAL PUMP SETS FOR USE WITH ROSS FLEXIFLO-III	May 02, 1990	Substantially Equivalent	DELMED, INC.
K895919	ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-III	May 02, 1990	Substantially Equivalent	DELMED, INC.
K895696	ENTERAL PUMP SET W/ENTERAL SPIKE FOR USE W/FEED PU	May 02, 1990	Substantially Equivalent	DELMED, INC.
K895366	ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE	May 02, 1990	Substantially Equivalent	FRESENIUS USA, INC.
K895330	600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTA	May 02, 1990	Substantially Equivalent	DELMED, INC.
K895246	FRENTA(R) DUO-SET	May 02, 1990	Substantially Equivalent	DELMED, INC.
K896210	GASTRIC SUMP TUBE	Jan 18, 1990	Substantially Equivalent	WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS)
K895706	TUBING ORGANIZER	Oct 31, 1989	Substantially Equivalent	3T PRODUCTS, INC.
K895616	L.T.C. FEEDING TUBE	Oct 24, 1989	Substantially Equivalent	INTL. MEDICAL MARKETING, INC.
K893888	HOLLISTER FEEDING TUBE ATTACHMENT DEVICE	Oct 17, 1989	Substantially Equivalent	HOLLISTER, INC.
K893541	VINYL BAG W/GRAVITY ADMINISTRATION SET	Oct 17, 1989	Substantially Equivalent	SANDOZ NUTRITION
K893540	VINYL BAG W/PUMP ADMINISTRATION SET	Oct 17, 1989	Substantially Equivalent	SANDOZ NUTRITION
K894857	PEDI-TUBE(R) STYLET	Oct 03, 1989	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K885220	PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT	Sep 25, 1989	Unknown	ETHOX CORP.
K891371	GILSDORF PERCU. ENDO.-PEG & PERCU. FLOURO.-PFG	Aug 03, 1989	Unknown	ENTECH, INC.
K893209	ENTERA-FLO SPIKE SET	Jul 24, 1989	Substantially Equivalent	DELMED, INC.
K890093	PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SET	Jul 24, 1989	Substantially Equivalent	KELLS MEDICAL, INC.
K892439	KENDALL CURITY STOMACH TUBES	Jun 23, 1989	Substantially Equivalent	THE KENDAL CO.
K890424	ENTERAL FEEDING CONTAINER	Jun 14, 1989	Substantially Equivalent	MULTI-MED, INC.
K890430	ENTAINER(TM) ENTERAL FEEDING CONTAINER	Jun 02, 1989	Substantially Equivalent	ENTECH, INC.
K890151	ENTERAL BAG/SET	May 23, 1989	Substantially Equivalent	ASHLEY HEALTH CARE, INC.
K891109	PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE	May 08, 1989	Substantially Equivalent	CONCEPT, INC.
K890871	BARD MOSS(R) GASTROSTOMY TUBE	Apr 27, 1989	Substantially Equivalent	C.R. BARD, INC.
K890870	BARD GASTROSTOMY FEEDING DEVICE	Apr 27, 1989	Substantially Equivalent	C.R. BARD, INC.
K885339	FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT	Mar 01, 1989	Substantially Equivalent	SUPERIOR HEALTHCARE GROUP, INC.
K890552	CP&S GAVAGE CONSTAINER, DISPOSABLE	Feb 24, 1989	Substantially Equivalent	CONSOLIDATED PRODUCTS & SERVICES, INC.
K884127	LAKE N/G FEEDING TUBE	Feb 08, 1989	Substantially Equivalent	LAKE MEDICAL PRODUCTS, INC.
K884275	FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT	Dec 22, 1988	Unknown	ABBOTT LABORATORIES
K884309	NH PEDIATRIC REPLACEMENT GASTROSTOMY KIT	Dec 08, 1988	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K884128	LAKE N/G EXTENSION SET	Dec 08, 1988	Substantially Equivalent	LAKE MEDICAL PRODUCTS, INC.
K884439	GASTROSTOMY FEEDING DEVICE	Dec 05, 1988	Substantially Equivalent	SOUTHSIDE BIOTECHNOLOGY
K883319	HILL NASOGASTRIC TUBE	Dec 05, 1988	Substantially Equivalent	ZINETICS MEDICAL, INC.
K882918	KIM NASO-INTESTINAL TUBE	Dec 05, 1988	Substantially Equivalent	SHERIDAN CATHETER CORP.
K882682	COMPAT ENTERAL DELIVERY SYSTEM	Oct 28, 1988	Substantially Equivalent	SANDOZ NUTRITION
K882867	CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE	Sep 21, 1988	Substantially Equivalent	CORPAK CO.
K882218	COMPAT (R) ENTERAL DELIVERY SYSTEM	Sep 13, 1988	Substantially Equivalent	SANDOZ NUTRITION
K882089	MRM GASTROSTOMY BELT	Sep 13, 1988	Substantially Equivalent	MRM PRODUCTS, INC.
K883351	PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING TUBE	Aug 23, 1988	Substantially Equivalent	GASTROTECH, INC.
K883336	GASTROSTOMY FEEDING TUBE	Aug 23, 1988	Substantially Equivalent	GASTROTECH, INC.
K880767	MIC NEEDLE JEJUNOSTOMY TUBE KIT	Aug 11, 1988	Substantially Equivalent	MEDICAL INNOVATIONS CORP.
K881978	ENTERAL FEEDING TUBES	Jul 13, 1988	Substantially Equivalent	PRIMROSE MEDICAL, INC.
K881162	ENTERA* ENTERAL FEEDING BAG	Jun 03, 1988	Substantially Equivalent	SMASH ENT., INC.
K875232	INTRO-REDUCER (NASOGASTRIC TUBE)	Jun 02, 1988	Substantially Equivalent	HEALTH IMPROVEMENT ASSOC.
K881310	DENT SLEEVE MANOMETRIC CATHETER	May 20, 1988	Substantially Equivalent	WILSON-COOK MEDICAL, INC.
K874154	ELECATH(R) TRANSESOPHAGEAL PACING CATHETER	Apr 29, 1988	Substantially Equivalent	ELECTRO-CATHETER CORP.
K880768	MIC (SPECIFIC LINE) REPLACEMENT KIT	Apr 22, 1988	Substantially Equivalent	MEDICAL INNOVATIONS CORP.
K880201	REPLACEMENT SILICONE GASTROSTOMY TUBE KIT #87600	Apr 14, 1988	Substantially Equivalent	SUPERIOR HEALTHCARE GROUP, INC.
K880051	ENTERAL BAG/SET	Apr 14, 1988	Substantially Equivalent	CHURCHILL CORP.
K874936	MEDSURG PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY	Apr 14, 1988	Substantially Equivalent	MEDSURG INDUSTRIES, INC.
K875171	J-CATH(TM)	Apr 06, 1988	Substantially Equivalent	HDC CORP.
K874755	EFFNER FE-EX* OROGASTRIC	Apr 06, 1988	Substantially Equivalent	EFFNER AND SPREINE CO.
K873360	ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG	Mar 30, 1988	Substantially Equivalent	ENDOVATIONS
K880232	NH REPLACEMENT GASTROSTOMY KIT	Mar 03, 1988	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K875126	MIC (SPECIFIC LINE) INSERTION KIT	Mar 02, 1988	Unknown	MEDICAL INNOVATIONS CORP.
K871848	NUTRITION DELIVERY SETS FOR VM 05 AMBULA. PUMP	Feb 03, 1988	Substantially Equivalent	PANAMEDIX, INC.
K874393	ENTERAL FEEDING TUBE	Dec 07, 1987	Substantially Equivalent	WILSON-COOK MEDICAL, INC.
K873343	ENTUBE-MEER AND MEER FEEDING TUBE BRIDLE SYSTEM	Dec 07, 1987	Substantially Equivalent	ENTECH, INC.
K872921	MSS ENTERAL DELIVERY SET	Dec 03, 1987	Substantially Equivalent	MEDICAL SUPPORT, INC.
K873441	BAKER TWIN-CUFF INTESTINAL DECOMP/PLICATION TUBE	Oct 27, 1987	Substantially Equivalent	BISSELL MEDICAL PRODUCTS, INC.
K872771	LOW PROFILE GASTROSTOMY	Oct 09, 1987	Substantially Equivalent	MICROVASIVE
K872932	MOSS(R) MARK IV NASAL TUBES CAT.# 87168	Sep 15, 1987	Substantially Equivalent	MFG. AND RESEARCH, INC.
K872531	MIC MUSHROOM TIP GASTROSTOMY TUBE	Sep 04, 1987	Substantially Equivalent	MEDICAL INNOVATIONS CORP.
K871846	FLEXIFLO TOPTAINER TOP-FILL ENTERAL NUTRIT. SYSTEM	Aug 26, 1987	Substantially Equivalent	ABBOTT LABORATORIES
K872097	INFANT FEEDING TUBE	Aug 25, 1987	Substantially Equivalent	TRI-STATE HOSPITAL SUPPLY CORP.
K872096	INFANT FEEDING KIT/SET NASOGASTRIC FEEDING KIT	Aug 25, 1987	Substantially Equivalent	TRI-STATE HOSPITAL SUPPLY CORP.
K871691	MODIFIED MULTI-LUMEN NASOGASTRIC TUBE	Aug 10, 1987	Substantially Equivalent	BISSELL MEDICAL PRODUCTS, INC.
K871528	ENTRIMIT GRAVITY FEEDING SET	Aug 10, 1987	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K871554	MOSS(R) GASTROSTOMY TUBE CAT #5-17719	Jul 21, 1987	Substantially Equivalent	MFG. AND RESEARCH, INC.
K871019	ENFUSE ENTERNAL ADMINISTRATION SET & PUMP SET	Jun 09, 1987	Substantially Equivalent	ENTECH, INC.
K871003	ENTROSET-SW	Jun 04, 1987	Substantially Equivalent	WHITE RIVER (TM)
K870508	GASTROINTESTINAL TUBE	May 11, 1987	Substantially Equivalent	PENN MEDICAL DEVICES, INC.
K864683	NEONATAL FEEDING KIT	Apr 17, 1987	Substantially Equivalent	SALT CREEK MEDICAL TECHNOLOGIES
K864364	WINDSOR SAFETY-TOP ENTERAL FEEDING BAG/BAG & SET	Feb 11, 1987	Substantially Equivalent	TECHNICAL ASSOCIATES OF NEW ENGLAND
K864218	PROCON	Jan 12, 1987	Substantially Equivalent	HEALTHCARE MANAGEMENT SYSTEMS
K861323	REPLACEMENT GASTROSTOMY TUBE	Dec 16, 1986	Substantially Equivalent	MICROVASIVE
K861309	JEJUNAL FEEDING TUBE	Dec 16, 1986	Substantially Equivalent	MICROVASIVE
K864182	ENTERAL ADMINISTRATION ADAPTERS	Dec 04, 1986	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K862855	CRAIG NASO-GASTRIC TUBE HOLDER	Nov 04, 1986	Substantially Equivalent	HENLEY INTL.
K861599	T-FASTENER	Oct 02, 1986	Substantially Equivalent	MEDI-TECH, INC.
K862573	HOLLISTER DRAIN TUBE ATTACHMENT	Sep 23, 1986	Substantially Equivalent	HOLLISTER, INC.
K862489	ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE	Sep 23, 1986	Substantially Equivalent	KNIGHT MEDICAL, INC.
K861494	EMPTY SOLUTION TRANSFER CONTAINER 1,500 ML	Aug 18, 1986	Substantially Equivalent	POLYMER TECHNOLOGIES
K862091	MCGAW NUTRA-FEED EFS ENTERAL FEEDING TUBE	Aug 14, 1986	Substantially Equivalent	KENDALL MCGAW LABORATORIES, INC.
K861862	DIETO CONTAINER FOR ENTERAL NUTRITION	Aug 11, 1986	Substantially Equivalent	GIL-MED INDUSTRIES C/O KEGAN & KEGAN, LTD.
K861427	ENTUBE TM, ENTERAL FEEDING TUBE	Jul 18, 1986	Substantially Equivalent	ENTECH, INC.
K861618	TRAVASORB FEEDING TUBES - (2L8014) AND (2L8024)	Jul 15, 1986	Substantially Equivalent	TRAVENOL LABORATORIES, S.A.
K861090	NUTRI-CATH - FEEDING TUBE	Jun 18, 1986	Substantially Equivalent	GESCO INTL., INC.
K861552	TOP-PORT ENTERAL FEEDING BAG AND PREATTACHED SETS	Jun 16, 1986	Substantially Equivalent	ENTECH, INC.
K860818	ONE TIME ENTERAL FEEDING BAG	May 15, 1986	Substantially Equivalent	ACME UNITED CORP.
K860991	SCLEROTHERAPY INJECTION CATHETER	May 02, 1986	Substantially Equivalent	ENDOVATIONS
K855098	COMPAT ENTERAL DELIVERY SYSTEMS	Apr 08, 1986	Substantially Equivalent	SANDOZ NUTRITION
K855097	COMPAT ENTERAL DELIVERY SYSTEMS	Apr 08, 1986	Substantially Equivalent	SANDOZ NUTRITION
K860589	INFLATOR/DEFLATOR PISTON SYRINGE	Apr 07, 1986	Substantially Equivalent	MICROVASIVE
K861051	ISOLIFE DISPENSING SYSTEM	Apr 03, 1986	Substantially Equivalent	NAVACO LABORATORIES
K860285	XRO GASTRO-DUODENAL, DUAL FLOW TUBE, SALEM TYPE	Feb 11, 1986	Substantially Equivalent	VYGON CORP.
K860052	QWIK-CALL	Feb 06, 1986	Substantially Equivalent	EMDE CORP.
K860075	DYNAFEED ENTERAL PUMP FEED BAG	Jan 23, 1986	Substantially Equivalent	MEDLINE INDUSTRIES, INC.
K854616	ENTERAL FEEDING BAG	Jan 23, 1986	Substantially Equivalent	MEDOVATIONS, INC.
K854660	THE MMG ENTERAL FEEDING ADMINISTRATION SET	Jan 21, 1986	Substantially Equivalent	MEDICAL TECHNOLOGIES OF GEORGIA
K855121	COLOSHIELD KIT	Jan 08, 1986	Substantially Equivalent	DEKNATEL, INC.
K854215	DYNAFEED	Dec 02, 1985	Substantially Equivalent	MEDLINE INDUSTRIES, INC.
K853384	E-Z-EM GASTRIC LAVAGE CATHETER	Nov 05, 1985	Substantially Equivalent	E-Z-EM, INC.
K853253	CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELI	Nov 05, 1985	Substantially Equivalent	CORPAK CO.
K853353	88000 GASTROSTOMY-JEJUNAL FEEDING TUBE KIT	Nov 04, 1985	Substantially Equivalent	SUPERIOR HEALTHCARE GROUP, INC.
K852552	COONS GASTROSTICK SYSTEM	Oct 17, 1985	Substantially Equivalent	MEDI-TECH, INC.
K852535	E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GASTROSTOMY	Oct 17, 1985	Substantially Equivalent	TRI-MED SPECIALTIES, INC.
K853288	FEEDING UNITS & TUBES	Oct 04, 1985	Substantially Equivalent	I M, INC.
K851975	ENTERAL FEEDING BAG, 1000 ML, & TUBING SET	Sep 05, 1985	Substantially Equivalent	VENUSA LTD.
K853309	P.A. ENTERAL FEEDING BAG 1100	Aug 27, 1985	Substantially Equivalent	PA MEDICAL CORP.
K852966	ENTERAL FEEDING CONTAINER	Aug 27, 1985	Substantially Equivalent	EMPIRE INDUSTRIES, INC.
K853197	MIC JEJUNAL FEEDING TUBE	Aug 22, 1985	Substantially Equivalent	MEDICAL INNOVATIONS CORP.
K852707	GASTRO-ENTEROSTOMY TUBE	Aug 14, 1985	Substantially Equivalent	MEDICAL INNOVATIONS CORP.
K852363	MIC GASTROSTOMY TUBE PERCUTANEOUS INSERTION KIT	Aug 09, 1985	Substantially Equivalent	MEDICAL INNOVATIONS CORP.
K852792	CORPAK ENTERAL SOL ADM PUMP SET W/ SCREW	Aug 08, 1985	Substantially Equivalent	CORPAK CO.
K851672	NYHUS/NELSON TUBE	Jul 09, 1985	Substantially Equivalent	BISSELL MEDICAL PRODUCTS, INC.
K850664	ENDO-TUBE	Jun 21, 1985	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K851671	GASTROINTESTINAL TUBE	Jun 14, 1985	Substantially Equivalent	SHERIDAN CATHETER CORP.
K851539	CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLO	Jun 12, 1985	Substantially Equivalent	CHESEBROUGH-POND'S U.S.A. CO.
K851444	KEITH-A.R.V.	May 10, 1985	Substantially Equivalent	KARL M. BLOCK CO.
K832170	MUFFLER GAS-AIR VENT UNIT	Apr 02, 1985	Substantially Equivalent	DR. EDWARD RICHARDS
K850182	IVAC KEOFEED II POLYURETHANE FEEDING TUBE	Mar 19, 1985	Substantially Equivalent	Y
K850134	ENTRON ENTERAL FEEDING BAG	Feb 14, 1985	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K843939	PEDIATRIC SIZE K-TUBE A OR B	Feb 14, 1985	Substantially Equivalent	MIDWEST METABOLIC SUPPORT GROUP
K843567	KANGAROO NASOGASTRIC FEEDING TUBE	Feb 14, 1985	Substantially Equivalent	CHESEBROUGH-POND'S U.S.A. CO.
K844745	K-TUBE	Jan 07, 1985	Substantially Equivalent	MIDWEST METABOLIC SUPPORT GROUP
K844789	KANGAROO ACCESS II ENTERAL FEEDING CONTAINER	Jan 02, 1985	Substantially Equivalent	CHESEBROUGH-POND'S U.S.A. CO.
K844203	ENTERNAL FEEDING TUBE SILICONE-EF401, 402 & 403	Jan 02, 1985	Substantially Equivalent	EXCO, INC.
K844175	ENTERNAL FEEDING TUBE-POLYURETHANE EF504	Jan 02, 1985	Substantially Equivalent	EXCO, INC.
K844174	FLEXIBLE STAINLESS STEEL STYLET FOR ENTERNAL FEEDI	Dec 07, 1984	Substantially Equivalent	EXCO, INC.
K842174	PERCUTANEOUS GASTROSTOMY TUBE	Dec 07, 1984	Substantially Equivalent	MOUNT CARMEL MERCY HOSPITAL
K844222	BIOSEARCH GLASER PEG PERCUTANEOUS ENDOSCOPIC GASTR	Dec 05, 1984	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K843975	9 FRENCH 42LONG POLYURETHANE GRADUATED ENTERIC FE	Nov 20, 1984	Substantially Equivalent	SUPERIOR PLASTIC PRODUCTS CORP.
K842808	URITROL-M	Nov 16, 1984	Substantially Equivalent	THE WASHINGTON GROUP, INC.
K843392	GAUDERER GASTROSTOMY BUTTON	Oct 11, 1984	Substantially Equivalent	AMERICAN V. MUELLER
K843305	DAVOL GAUDERER-PONSKY PERCUTAN-ENDOSCOP	Oct 11, 1984	Substantially Equivalent	C.R. BARD, INC.
K841986	PROTOMED/TOWIC NASOGASTRIC TUBE DRAINAGE BAG	Sep 10, 1984	Substantially Equivalent	PROTOMED CORP.
K842841	VIVONEX TUNG STEN TIP TUBE	Aug 14, 1984	Substantially Equivalent	NORWICH EATON PHARMACEUTICALS, INC.
K842589	IVAC KEOFEED HYDROPHILIC FEEDING TUBE	Aug 14, 1984	Substantially Equivalent	Y
K842076	MIC GASTROSTOMY TUBE	Aug 14, 1984	Substantially Equivalent	MEDICAL INNOVATIONS CORP.
K841945	ENTERAL FEEDING BOTTLE	Jul 26, 1984	Substantially Equivalent	SUPERIOR PLASTIC PRODUCTS CORP.
K841349	ESOPHAGEAL TUBE	Jul 23, 1984	Substantially Equivalent	E. BENSON HOOD LABORATORIES, INC.
K841428	JEJUNOSTOMY SET FOR TUBE FEEDING	Jul 09, 1984	Substantially Equivalent	BURRON MEDICAL PRODUCTS, INC.
K841289	RECTAL IRRIGATION TUBE	Jul 06, 1984	Substantially Equivalent	HDC CORP.
K840864	GORE-TEX CATHETER	Jun 01, 1984	Substantially Equivalent	W.L. GORE & ASSOCIATES,INC
K841330	GASTROSTOMY FEEDING TUBE	May 22, 1984	Substantially Equivalent	MICROVASIVE
K840752	ENTEROCYSIS TUBE W/GUIDE WIRE & CONNECT	May 02, 1984	Substantially Equivalent	E-Z-EM, INC.
K841014	WEIGHTED FEEDING TUBE W/PRE-INSERTED	May 01, 1984	Substantially Equivalent	ETHOX CORP.
K841039	CANTOR TUBE	Apr 13, 1984	Substantially Equivalent	INMED CORP.
K841038	BLAKEMORE TUBE	Apr 13, 1984	Substantially Equivalent	INMED CORP.
K841036	RECTAL BALLOON CATHETERS	Apr 13, 1984	Substantially Equivalent	INMED CORP.
K841035	ULTRA BAKER JEJUNOSTOMY TUBE	Apr 13, 1984	Substantially Equivalent	INMED CORP.
K841034	DEAVER T-DRAIN & CATTEL T-DRAIN	Apr 13, 1984	Substantially Equivalent	INMED CORP.
K841033	MILLER-ABBOTT TUBE	Apr 13, 1984	Substantially Equivalent	INMED CORP.
K840916	DIETO CONTAINER FOR ENTERNAL NUTRIT	Apr 04, 1984	Substantially Equivalent	GIL-MED INDUSTRIES C/O KEGAN & KEGAN, LTD.
K840656	ENTERNAL Y EXTENSION SET RECORDER	Apr 04, 1984	Substantially Equivalent	CORPAK MEDSYSTEMS
K840936	NEEDLE CATHETER JEJUNOSTOMY REPAIR KIT	Mar 22, 1984	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K833687	DISPOS. ENTERIC FEEDING TUBES W/SAFE-T	Mar 02, 1984	Substantially Equivalent	SUPERIOR PLASTIC PRODUCTS CORP.
K834562	ENTERNAL FEEDING TUBE	Feb 13, 1984	Substantially Equivalent	SHERIDAN CATHETER CORP.
K840019	K-TUBE REPAIR KIT	Feb 10, 1984	Substantially Equivalent	MIDWEST METABOLIC SUPPORT GROUP
K834554	ETHOX WEIGHTED FEEDING TUBE	Feb 10, 1984	Substantially Equivalent	ETHOX CORP.
K834268	ISLAMI GASTROINTESTINAL TUBE	Feb 04, 1984	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K834258	HODGE DECOMPRESSION TUBE	Feb 04, 1984	Substantially Equivalent	INMED CORP.
K833947	SUPERIOR ENTERNAL FEEDING SYSTEM	Feb 04, 1984	Substantially Equivalent	SUPERIOR PLASTIC PRODUCTS CORP.
K832093	FEEDING GASTROSTOMY TUBE	Feb 04, 1984	Substantially Equivalent	TRI-MED, INC.
K833492	PERCUTANEOUS ENDOSCOPIC GASTROSCOPY	Nov 29, 1983	Substantially Equivalent	AMERICAN ENDOSCOPY, INC.
K833621	ENTRI FLEX FEEDING TUBE	Nov 28, 1983	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K833591	FEEDING TUBE	Nov 28, 1983	Substantially Equivalent	MEDOVATIONS, INC.
K833513	NEEDLE CATHETER JEJUNOSTOMY KIT	Nov 28, 1983	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K832859	FOAM HELMET - USE W/ESOPHAGEAL TAMPONA	Nov 14, 1983	Substantially Equivalent	INMED CORP.
K833293	LEIDER FEEDING TUBE W/HYDROMER LUBR	Oct 31, 1983	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K832966	FLEXIFLO ENTERAL FEEDING TUBE	Oct 31, 1983	Substantially Equivalent	ABBOTT LABORATORIES
K833054	GASTRIC SUMP TUBES	Oct 19, 1983	Substantially Equivalent	MEDOVATIONS, INC.
K832927	GRAVITY ENTERAL FEEDING SET	Oct 14, 1983	Substantially Equivalent	MEDICAL CONNECTIONS
K832196	SHERIDAN/LEVI-A-SUMP	Oct 14, 1983	Substantially Equivalent	SHERIDAN CATHETER CORP.
K832672	FOUR LUMEN BLAKEMORE TUBE	Sep 12, 1983	Substantially Equivalent	INMED CORP.
K832293	ENTERNAL FEEDING TUBE	Sep 12, 1983	Substantially Equivalent	CONCEPT, INC.
K831971	VIVONEX TUNGSTEN TIP TUBE-TWISTED WIRE	Sep 01, 1983	Substantially Equivalent	NORWICH EATON PHARMACEUTICALS, INC.
K831969	VIVONEX TUNGSTEN TIP TUBE-WOUND	Sep 01, 1983	Substantially Equivalent	NORWICH EATON PHARMACEUTICALS, INC.
K831968	VIVONEX TUNGSTEN TIP TUBE-BRAIDED	Sep 01, 1983	Substantially Equivalent	NORWICH EATON PHARMACEUTICALS, INC.
K832501	ENEMA TUBE	Aug 31, 1983	Substantially Equivalent	CONE INSTRUMENTS, INC.
K831847	JEJUNOSTOMY KIT	Aug 31, 1983	Substantially Equivalent	ACCU-LINE
K831840	FEEDING TUBE PLACEMENT STYLET	Aug 12, 1983	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K831823	AXIOM FEEDING GASTRO TUBE	Aug 12, 1983	Substantially Equivalent	AXIOM MEDICAL, INC.
K831631	GASTROSTOMY FEEDING SET	Aug 12, 1983	Substantially Equivalent	PLASCO, INC.
K831328	NEONATAL NASOGASTRIC FEEDING TUBE-	Jul 19, 1983	Substantially Equivalent	CORPAK MEDSYSTEMS
K831974	STOMACH TUBE LEVIN TUBE	Jul 18, 1983	Substantially Equivalent	MEDLINE INDUSTRIES, INC.
K831970	VIVONEX TUNGSTEN TIP TUBE-MONOFILA-	Jul 18, 1983	Substantially Equivalent	NORWICH EATON PHARMACEUTICALS, INC.
K831868	DOBBHOFF FEEDING TUBE W/HYDROMER LUB	Jul 12, 1983	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K823475	BROOKS SCLEROTHERAPY CUFF	Jul 12, 1983	Substantially Equivalent	INMED CORP.
K831009	CANTOR TUBE	Jun 02, 1983	Substantially Equivalent	MEDOVATIONS, INC.
K830998	MILLER-ABBOTT TUBE	Jun 02, 1983	Substantially Equivalent	MEDOVATIONS, INC.
K830990	BLAKEMORE TUBE	Jun 02, 1983	Substantially Equivalent	MEDOVATIONS, INC.
K830989	BAKER JEJUNOSTOMY TUBE	Jun 02, 1983	Substantially Equivalent	MEDOVATIONS, INC.
K830987	LEVIN TUBE	May 27, 1983	Substantially Equivalent	MEDOVATIONS, INC.
K830986	RECTAL TUBES	May 27, 1983	Substantially Equivalent	MEDOVATIONS, INC.
K830985	STOMACH TUBE	May 27, 1983	Substantially Equivalent	MEDOVATIONS, INC.
K830794	ARGYLE MADEN SILICONE GASTROSTOMY TUBE	May 18, 1983	Substantially Equivalent	SHERWOOD MEDICAL CO.
K831168	ENTERAL DELIVERY SET	May 09, 1983	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K831167	ENTERAL PUMP SET	May 09, 1983	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K831169	TOP-FILL BAG	Apr 28, 1983	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K830965	ENTERAL SOLUTION ADMIN. PUMP SET	Apr 18, 1983	Substantially Equivalent	CORPAK CO.
K830710	ARGYLE SILICONE SALEM SUMP TUBE	Mar 29, 1983	Substantially Equivalent	SHERWOOD MEDICAL CO.
K830119	NEEDLE CATHETER JEJUNOSTOMY KIT	Jan 28, 1983	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K823195	GASTRIC LAVAGE KIT	Dec 03, 1982	Substantially Equivalent	AUTOVAGE
K822087	DIA SCOPE	Nov 17, 1982	Substantially Equivalent	EXITEC, INC.
K823082	TRAVASORB NASOGASTRIC NASOINTESTINAL	Nov 16, 1982	Substantially Equivalent	TRAVENOL LABORATORIES, S.A.
K822879	ENTERAL NUTRITION 1	Nov 16, 1982	Substantially Equivalent	EXCO, INC.
K822004	FACE SHIELDS	Oct 20, 1982	Substantially Equivalent	KELLEHER CORP.
K822875	PEDI-TUBE PEDIATRIC FEEDING TUBE	Oct 13, 1982	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K822565	NEEDLE CATHETER JEJUNOSTOMY KIT	Sep 28, 1982	Substantially Equivalent	BIO-RESEARCH ASSOCIATES, INC.
K822380	ROMBEAU GASTROSTOMY-JEJUNAL TUBE	Sep 17, 1982	Substantially Equivalent	HEDECO
K822631	ARGYLE DUO-TUBE	Sep 09, 1982	Substantially Equivalent	SHERWOOD MEDICAL CO.
K822228	GASTRO VAGE SET FOR GASTRIC LAVAGE	Sep 09, 1982	Substantially Equivalent	ACKRAD LABORATORIES
K822443	NASO-GARD NASOGASTRIC TUBE HOLDER	Sep 02, 1982	Substantially Equivalent	AMERICAN PHARMASEAL DIV. AHSC
K821825	CONPHAR SILICONE FEEDING TUBE	Aug 10, 1982	Substantially Equivalent	CONPHAR, INC.
K821906	CORPAK ENTERIC FEEDING TUBE W/GUIDE TIP	Jul 13, 1982	Substantially Equivalent	CORPAK MEDSYSTEMS
K821410	CORPAK-MONITOR ENTERAL FEEDING CONTAIN	May 24, 1982	Substantially Equivalent	CORPAK CO.
K821409	CORPAK-ENTERAL FEEDING CONTAINER	May 24, 1982	Substantially Equivalent	CORPAK CO.
K821231	VIVONEX TUNGSTEN TIP TUBE PLACEMENT	May 10, 1982	Substantially Equivalent	NORWICH EATON PHARMACEUTICALS, INC.
K821067	VIVONEX ACUTROL ENTERNAL FEEDING SYS	Apr 29, 1982	Substantially Equivalent	NORWICH EATON PHARMACEUTICALS, INC.
K821036	ENTERNAL SOLUTION ADMIN. SET	Apr 26, 1982	Substantially Equivalent	CORPAK CO.
K813585	WATERS ILEOSTOMY VALVE	Apr 09, 1982	Substantially Equivalent	WATERS INSTRUMENTS, INC.
K820420	AM. PH. STERILE FEEDING TUBE	Mar 23, 1982	Substantially Equivalent	AMERICAN PHARMASEAL DIV. AHSC
K820442	ARGYLE INDWELL FEEDING TUBE	Mar 10, 1982	Substantially Equivalent	SHERWOOD MEDICAL CO.
K820441	ARGYLE PVC FEEDING TUBE	Mar 10, 1982	Substantially Equivalent	SHERWOOD MEDICAL CO.
K820176	VYGON ENTERNAL NUTRITION TUBES	Feb 05, 1982	Substantially Equivalent	EXCO, INC.
K813526	FECAL SANITARY TUBE	Jan 12, 1982	Substantially Equivalent	LEON'S FECAL SANITARY TUB MFG.
K813132	THE CHICAGO GULLET	Jan 07, 1982	Substantially Equivalent	UNIVERSAL PROSTHETICS, INC.
K813169	CELESTIN PULSION ESOPHOGEAL PROSTHESIS	Dec 03, 1981	Substantially Equivalent	INMED CORP.
K812648	EHTOX GASTRIC LAVAGE KIT #2050 & #2070	Sep 29, 1981	Substantially Equivalent	ETHOX CORP.
K812427	CARTMILL/BARRY FEEDING TUBE	Sep 23, 1981	Substantially Equivalent	IMPRA, INC.
K812507	THE KEOFEED STOMACH TUBE	Sep 14, 1981	Substantially Equivalent	HEDECO
K812102	O.N.A.T.	Aug 31, 1981	Substantially Equivalent	LATEX MEDICAL DEVICES, INC.
K812279	ENTER-A1 ENTERIC FEEDING TUBE	Aug 25, 1981	Substantially Equivalent	MEDI-TECH, INC.
K811968	VIVONEX TUNGSTEN TIP	Aug 25, 1981	Substantially Equivalent	NORWICH EATON PHARMACEUTICALS, INC.
K811683	ENTRI ENTERNAL FEEDING SET	Jul 15, 1981	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K811533	MGN FEEDING TUBE	Jul 10, 1981	Substantially Equivalent	MGN MEDICAL MANUFACTURING, INC.
K811639	ETHIX FEEDING TUBES POLYURETHANE/RADIOP.	Jun 26, 1981	Substantially Equivalent	ETHOX CORP.
K811061	AUTOMATED GASTRIC LAVAGE	Jun 23, 1981	Substantially Equivalent	EMERGENCY MEDICINE
K810979	ARROW NEEDLE-CATHETER JEJUNOSTOMY KIT	Jun 02, 1981	Substantially Equivalent	ARROW INTL., INC.
K810996	ENTERNAL PUMP SET W/INTEGRAL CONTAINER	Apr 29, 1981	Substantially Equivalent	ABBOTT LABORATORIES
K810573	TUBE FEEDING SET	Apr 23, 1981	Substantially Equivalent	HARVARD LABORATORIES
K810854	KANGAROO NASOGASTRIC FEEDING TUBE	Apr 17, 1981	Substantially Equivalent	CHESEBROUGH-POND'S U.S.A. CO.
K810250	TRAY, IRRIGATION	Apr 07, 1981	Substantially Equivalent	MEGAPLAST, INC.
K810392	OESOPHAGEAL THERAPY KIT	Mar 31, 1981	Substantially Equivalent	KEYMED, INC.
K810499	PERCUTANEOUS GASTROINTESTINAL TUBE	Mar 04, 1981	Substantially Equivalent	HEALTH DEVELOPMENT CORP.
K810156	ARGYLE SALEM SUMP TUBE	Mar 02, 1981	Substantially Equivalent	SHERWOOD MEDICAL CO.
K802585	FEEDING TUBES IN SILICONE 5,6,8&10 SIZES	Oct 31, 1980	Substantially Equivalent	THE HEALTHCARE GROUP LABORATORIES, INC.
K802482	KEOFEED (R) EASY-FILL ENTERIC FEED BAG	Oct 31, 1980	Substantially Equivalent	HEALTH DEVELOPMENT CORP.
K802300	VIVONEX JEJUNOSTOMY KIT	Oct 23, 1980	Substantially Equivalent	NORWICH EATON PHARMACEUTICALS, INC.
K801558	ENTERIC FEEDING TUBE W/SEGM. FLEX. WT.	Jul 28, 1980	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K801511	NASO-GARD NASOGASTRIC TUBE HOLDER	Jul 28, 1980	Substantially Equivalent	HOWMEDICA CORP.
K801498	ENTRI NASOGASTRIC FEEDING TUBE	Jul 28, 1980	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K800918	MODIFIED FEEDING JEJUNOSTOMY TUBE	Jul 28, 1980	Substantially Equivalent	MITCHELL V. KAMINSKI, JR., M.D.
K800815	ENTERAL & NASOGASTRIC SOL. ADMIN. SET	Jul 21, 1980	Substantially Equivalent	G.D. SEARLE AND CO.
K800955	TUBE FEEDING CONTAINER 1500 ML DISPOSE.	May 30, 1980	Substantially Equivalent	THE HEALTHCARE GROUP LABORATORIES, INC.
K800510	RECTAL & HARRIS FLUSH TUBES	Apr 08, 1980	Substantially Equivalent	MEDI-CRAFT LTD.
K800508	STOMACH TUBES	Apr 08, 1980	Substantially Equivalent	MEDI-CRAFT LTD.
K800507	FEEDING TUBES	Apr 08, 1980	Substantially Equivalent	MEDI-CRAFT LTD.
K792597	RECTAL LEAKAGE INHIBITOR	Feb 06, 1980	Substantially Equivalent	AUGUSTIN JONES, M.D.
K792333	BAKER INTESTINAL TUBE, TWIN CUFF	Jan 16, 1980	Substantially Equivalent	INTL. HOSPITAL PRODUCTS, INC.
K791714	SURGIFEED	Jan 16, 1980	Substantially Equivalent	HEALTH DEVELOPMENT CORP.
K791758	CLINIFEEDING SYSTEM 1	Oct 26, 1979	Substantially Equivalent	ROUSSEL (CANADA) LTD.
K791269	CONPHAR STOMACH TUBE-STERILE	Aug 03, 1979	Substantially Equivalent	CONPHAR, INC.
K791268	CONPHAR RECTAL TUBE-STERILE	Aug 03, 1979	Substantially Equivalent	CONPHAR, INC.
K791257	CONPHAR FEEDING TUBE-STERILE	Aug 03, 1979	Substantially Equivalent	CONPHAR, INC.
K791250	CONPHAR STOMACH TUBE-STERILE-X-RAY	Aug 03, 1979	Substantially Equivalent	CONPHAR, INC.
K790612	NUTRIFLOW NASOGASTRIC FEEDING TUBE	May 11, 1979	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K790387	FEEDING TUBE W/ LUBRICANT COATING	Apr 04, 1979	Substantially Equivalent	BIOSEARCH MEDICAL PRODUCTS, INC.
K781230	GAVAGE ADMIN. SET	Sep 07, 1978	Substantially Equivalent	MCGAW LABORATORIES
K760945	SILASTIC PERCUTANEOUS GASTROINTEST. TUBE	Nov 23, 1976	Substantially Equivalent	DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K760708	SILASTIC BRAND Q7-2091 GASTRIC SUMP TUBE	Nov 23, 1976	Substantially Equivalent	DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS

FEI Numbers

This FDA classification entry is associated with 242 FEI numbers. Click on an entry to view related FDA registrations.

1000112877: 433 registrations

1000112968: 424 registrations

1000120555: 57 registrations

1000121056: 328 registrations

1000132370: 44 registrations

1000136269: 265 registrations

1000138054: 760 registrations

1000160458: 173 registrations

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1000317571: 30 registrations

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1000514656: 190 registrations

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1024404: 30 registrations

1030583: 33 registrations

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1047843: 371 registrations

1048735: 291 registrations

1119193: 13 registrations

1213809: 17 registrations

1214422: 8 registrations

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1220592: 22 registrations

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1221765: 26 registrations

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2518902: 138 registrations

2528981: 215 registrations

3000203066: 50 registrations

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3002807308: 31 registrations

3002807314: 432 registrations

3002807391: 147 registrations

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3004111573: 356 registrations

3004122598: 110 registrations

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3005011024: 409 registrations

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3007697249: 15 registrations

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3008044552: 12 registrations

3008311916: 15 registrations

3008806809: 98 registrations

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3008824097: 46 registrations

3009211636: 67 registrations

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3009632672: 30 registrations

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3010041511: 587 registrations

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3010155661: 185 registrations

3010220595: 187 registrations

3010273872: 290 registrations

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3010400865: 57 registrations

3010452421: 69 registrations

3010594263: 41 registrations

3010605677: 176 registrations

3010757606: 4 registrations

3010761399: 3 registrations

3010958377: 1 registration

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3011088743: 53 registrations

3011237770: 70 registrations

3011270181: 132 registrations

3011285025: 15 registrations

3011324393: 8 registrations

3011707784: 40 registrations

3011802696: 5 registrations

3011987967: 104 registrations

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3012421607: 606 registrations

3012441529: 5 registrations

3012481535: 7 registrations

3012494290: 762 registrations

3012568936: 22 registrations

3012636179: 178 registrations

3012881740: 6 registrations

3013234390: 10 registrations

3013298431: 204 registrations

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3013524793: 5 registrations

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3014421917: 283 registrations

3014620201: 39 registrations

3014637079: 29 registrations

3014656668: 14 registrations

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3015173212: 285 registrations

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3015479927: 8 registrations

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7682: 25 registrations