Product Code: HIF FDA class 2 21 CFR 884.1730

Insufflator, Laparoscopic

Obstetrics/Gynecology

The Laparoscopic Insufflator is a device that introduces carbon dioxide gas into the peritoneal cavity to create and maintain a pneumoperitoneum, providing the working space necessary for laparoscopic surgical procedures. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HIF, regulated under 21 CFR 884.1730, within the Obstetrics/Gynecology specialty. No special risk flags apply.

View on FDA

510(k)s

177

FEI Numbers

141

Registration Numbers

141

Unique Applicants

101

Years Active

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Basic Information

Product Code: HIF
Device Class: FDA class 2
Regulation Number: 884.1730
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
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 177 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252318	Insufflator (OPTO-IFL1000)	Apr 16, 2026	Substantially Equivalent	Guangdong Optomedic Technologies, Inc.
K250388	ENDOFLATOR +	Sep 22, 2025	Substantially Equivalent	Karl Storz SE & CO. KG
K242772	AirSurgN Insufflator (10030/AirSurgN)	Apr 11, 2025	Substantially Equivalent	SmartsurgN, Inc.
K243527	High Flow Insufflation Unit (UHI-4)	Jan 13, 2025	Substantially Equivalent	Olympus Medical Systems Corporation
K242536	TauTona Pneumoperitoneum Assist Device (TPAD)	Oct 15, 2024	Substantially Equivalent	Tautona Group
K232902	EVA15 insufflator	May 02, 2024	Substantially Equivalent	Palliare , Ltd.
K232464	VereSee Optical Veres Needle System	May 02, 2024	Substantially Equivalent	Freyja Healthcare, LLC
K233020	TauTona Pneumoperitoneum Assist Device (TPAD)	Jan 12, 2024	Substantially Equivalent	Tautona Group Research & Development, Co., LLC
K232401	Disposable Veress Needles	Dec 14, 2023	Substantially Equivalent	Hangzhou Kangji Medical Instrument Co., Ltd.
K231342	Insufflator (OPTO-IFL1000)	Sep 20, 2023	Substantially Equivalent	Guangdong Optomedic Technologies, Inc.
K230239	AirSeal iFS System; AirSeal dV Solution	Sep 20, 2023	Substantially Equivalent	Conmed Corporation
K231407	StarFin	Aug 29, 2023	Substantially Equivalent	Premium Medical Technology, LLC
K222812	Insufflator	May 16, 2023	Substantially Equivalent	Scivita Medical Technology Co., Ltd.
K221995	Gas Insufflator	Mar 28, 2023	Substantially Equivalent	Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
K222901	EVA15 insufflator	Jan 27, 2023	Substantially Equivalent	Palliare , Ltd.
K212786	LevaLap Laparoscopic Access Device	Feb 23, 2022	Substantially Equivalent	Core Access Surgical Technologies, Inc.
K211104	AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set	Aug 19, 2021	Substantially Equivalent	Conmed Corporation
K202799	EVA15	Oct 21, 2020	Substantially Equivalent	Palliare , Ltd.
K201361	PNEUMOCLEAR	Jul 29, 2020	Substantially Equivalent	W.O.M. World of Medicine GmbH
K193520	EVA 15 Insufflator	Jul 23, 2020	Substantially Equivalent	Palliare , Ltd.
K193339	GTK Veress Needles	Jan 30, 2020	Substantially Equivalent	Guangzhou T.K Medical Instrument Co., Ltd.
K191780	AP50/30 Insufflator with Insuflow Port	Aug 28, 2019	Substantially Equivalent	Lexion Medical, LLC
K190303	AirSeal	Mar 28, 2019	Substantially Equivalent	Conmed Corporation
K172835	GRI-Alleset Veress Needle	Jun 11, 2018	Substantially Equivalent	Gri Medical and Electronic Technology Co., Ltd.
K172516	SurgiQuest AIRSEAL iFS System	Mar 16, 2018	Substantially Equivalent	Conmed Corporation
K173545	TEMED Gas Diffuser	Feb 14, 2018	Substantially Equivalent	Temed
K170799	AP 50/30 Insufflator with Insuflow Port	Nov 14, 2017	Substantially Equivalent	Lexion Medical, LLC
K162582	HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit	Jun 23, 2017	Substantially Equivalent	Fisher & Paykel Healthcare
K171139	LaparoLight Veress Needle	May 18, 2017	Substantially Equivalent	Buffalo Filter, LLC
K170784	PNEUMOCLEAR	May 15, 2017	Substantially Equivalent	W.O.M. World of Medicine GmbH
K161554	ENDOFLATOR 40, ENDOFLATOR 50	Mar 02, 2017	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K162648	U-Blade Veress Needle	Dec 12, 2016	Substantially Equivalent	Tianjin Uwell Medical Device Manufacturing Co., Ltd.
K153367	S698 Symbioz flow	Jun 17, 2016	Substantially Equivalent	Sopro - Acteon Group
K153513	Insufflator 50L FM134	Mar 04, 2016	Substantially Equivalent	W.O.M. World of Medicine GmbH
K150068	Unimicro Veress Needle	Jul 31, 2015	Substantially Equivalent	Unimicro Medical Systems (Shenzhen) Co., Ltd.
K143404	SurgiQuest AirSeal iFS System	Mar 20, 2015	Substantially Equivalent	Surgiquest, Inc.
K142700	InsufflatOR Needle	Dec 19, 2014	Substantially Equivalent	Gynetech Pty. , Ltd.
K140263	INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT	Mar 05, 2014	Substantially Equivalent	Lexion Medical, LLC
K132203	PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA	Sep 20, 2013	Substantially Equivalent	Lexion Medical, LLC
K132204	INSUFLOW SYNERGY XL PORT	Aug 22, 2013	Substantially Equivalent	Lexion Medical, LLC
K122180	HIGH FLOW INSUFFLANTION UNIT	Nov 13, 2012	Substantially Equivalent	Olympus Medical Systems Corporation
K120151	NEBULAE I	Aug 17, 2012	Substantially Equivalent	Northgate Technologies, Inc.
K120640	INSUFLOW SYNERGY PORT	Jul 18, 2012	Substantially Equivalent	Lexion Medical, LLC
K121336	MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000	Jul 03, 2012	Substantially Equivalent	Surgiquest, Inc.
K112975	CARBONAID C02 DIFFUSER	Jun 22, 2012	Substantially Equivalent	Cardia Innovation AB
K110294	HIGH FLOW INSUFFLATION UNIT UHI-4	Nov 18, 2011	Substantially Equivalent	Olympus Medical Systems Corporation
K111955	MEDLINE PNEUMOPERITONEUM NEEDLE	Nov 16, 2011	Substantially Equivalent	Medline Industries, Inc.
K112357	VESSEL GUARDIAN	Nov 10, 2011	Substantially Equivalent	Lexion Medical, LLC
K111441	UNIMAX VERESS NEEDLE	Aug 19, 2011	Substantially Equivalent	Unimax Medical Systems, Inc.
K103692	SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000	May 25, 2011	Substantially Equivalent	Surgiquest, Inc.
K102136	VESSEL GUARDIAN	Sep 27, 2010	Substantially Equivalent	Lexion Medical, LLC
K101320	VASOVAPOR	Jun 24, 2010	Substantially Equivalent	Lexion Medical, LLC
K090652	ALPHA DUO LAP INSUFFLATOR	Sep 25, 2009	Substantially Equivalent	Hippokratec GmbH
K091366	INSUFLOW DEWHEART	Sep 03, 2009	Substantially Equivalent	Lexion Medical, LLC
K090456	INSUFLOW	Aug 26, 2009	Substantially Equivalent	Lexion Medical, LLC
K080852	KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1	Mar 30, 2009	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K072753	REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES	Jan 25, 2008	Substantially Equivalent	Rg Medical USA
K073452	MODIFICATION TO: ARAGON SURGICAL LAPCAP	Jan 11, 2008	Substantially Equivalent	Aragon Surgical, Inc.
K070783	SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR	Dec 13, 2007	Substantially Equivalent	Sopro
K070651	ARAGON SURGICAL LAPCAP	May 30, 2007	Substantially Equivalent	Aragon Surgical, Inc.
K063367	45L CORE INSUFFLATOR, MODEL F114	May 23, 2007	Substantially Equivalent	W.O.M. World of Medicine AG
K063546	INSUFLOW DEVICE, MODEL 6198	Jan 10, 2007	Substantially Equivalent	Lexion Medical, LLC
K061387	VERESURE BELL	Jul 21, 2006	Substantially Equivalent	Veresure, Inc.
K060723	40 L HIGH FLOW INSUFFLATOR F113	May 25, 2006	Substantially Equivalent	W.O.M. World of Medicine AG
K052125	CARBONAID GAS DIFFUSER	Feb 08, 2006	Substantially Equivalent	Cardia Innovation AB
K041560	FLO-ASSISTANT	Sep 28, 2004	Substantially Equivalent	Northgate Technologies, Inc.
K033614	MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215	Jul 29, 2004	Substantially Equivalent	Northgate Technologies, Inc.
K030837	40 L HIGH FLOW INSUFFLATOR F108	Feb 05, 2004	Substantially Equivalent	W.O.M. World of Medicine AG
K033991	MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET	Jan 22, 2004	Substantially Equivalent	Pall Medical
K031014	HI-FLO THERME PNEU 45, WISAP #7083, 7083V	Jun 27, 2003	Substantially Equivalent	Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
K030469	LAPAROSHIELD CONDITIONED INSUFFLATION SET	May 09, 2003	Substantially Equivalent	Pall Medical
K022052	40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0	Jan 24, 2003	Substantially Equivalent	Northgate Technologies, Inc.
K021247	PNEUMOPERITONEUM INSUFFLATION NEEDLE	Nov 08, 2002	Substantially Equivalent	Mectra Labs, Inc.
K022318	VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES	Sep 19, 2002	Substantially Equivalent	Vomed Volzer Medizintechnik GmbH & Co.
K014166	UHI-3 HIGH FLOW INSUFFLATION UNIT	Jun 25, 2002	Substantially Equivalent	Olympus Optical Co., Ltd.
K011510	MULTI HI-FLO PNEU, WISAP #7080	Apr 02, 2002	Substantially Equivalent	Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
K010053	HUMI-FLOW, MODEL 6-850-00/ 01/02	Oct 23, 2001	Substantially Equivalent	Northgate Technologies, Inc.
K002328	SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR	Aug 27, 2001	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K000180	TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP	Mar 02, 2001	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K003703	TAUT-INSUFFLATION NEEDLE	Feb 22, 2001	Substantially Equivalent	Taut, Inc.
K003792	STRYKER HEATED INSUFFLATOR TUBE SET	Feb 21, 2001	Substantially Equivalent	Stryker Corp.
K001533	SURGIFLATOR-40	Jul 31, 2000	Substantially Equivalent	W.O.M. Gmhb
K993625	INSUFFLATION NEEDLE- 120MM, MODEL 900-200	Jun 20, 2000	Substantially Equivalent	Genicon, LC
K001068	NBS CONNECTING TUBE SET	Jun 14, 2000	Substantially Equivalent	Nbs Products CO
K000027	INSUFFLATION NEEDLE, MODEL R65-933	Apr 03, 2000	Substantially Equivalent	A & A Medical, Inc.
K991906	LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT	Nov 23, 1999	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K990662	DISPOSABLE HEATING TUBING SET #7642HSES	Sep 24, 1999	Substantially Equivalent	Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
K992381	CO2 GAS WARMER II, MODEL 6-800-00	Sep 17, 1999	Substantially Equivalent	Northgate Technologies, Inc.
K983326	OMNIFLATOR 7640 MODEL 7-640-00	Feb 05, 1999	Substantially Equivalent	Northgate Technologies, Inc.
K983925	ENDOPATH ULTRA VERESS NEEDLE	Feb 03, 1999	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K973447	OMNIFLATOR 6630(6-630-00)	Sep 30, 1998	Substantially Equivalent	Northgate Technologies, Inc.
K972675	CO2 GAS WARMING UNIT (6-800-00)	Sep 30, 1998	Substantially Equivalent	Northgate Technologies, Inc.
K981334	LAPARO CO2-PNEU (AND WITH VIDEO MONITORING)	Sep 10, 1998	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K981859	SURGIFLATOR-20 ECU	Jun 26, 1998	Substantially Equivalent	W.O.M. World of Medicine GmbH
K980134	KSEA N2O ENDOFLATOR	Apr 15, 1998	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K970866	FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER	Jan 23, 1998	Substantially Equivalent	Georgia Biomedical, Inc.
K973432	SURGIFLATOR-30	Dec 09, 1997	Substantially Equivalent	W.O.M. World of Medicine GmbH
K955477	HI-TEC CO2 INSUFFLATOR TYPE 1300	Aug 06, 1997	Substantially Equivalent	Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz
K963423	KSEA CO2 ENDOFLATOR	May 27, 1997	Substantially Equivalent	Karl Storz Endoscopy
K962683	SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR	Jan 10, 1997	Substantially Equivalent	Deknatel, Inc.
K955393	NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE	Jan 09, 1997	Substantially Equivalent	Surgical Innovations Plc
K955791	SURGIFLATOR-20 PIM	Dec 17, 1996	Substantially Equivalent	W.O.M. World of Medicine GmbH
K955073	KSEA THERMOFLATOR (MODEL 26 4320 20)	Dec 06, 1996	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K962863	KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR	Nov 19, 1996	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K950035	SURGIFLATOR 20	Feb 12, 1996	Substantially Equivalent	W.O.M. GmbH
K953162	OLYMPUS HIGH FLOW INSUFFLATION UNIT	Dec 19, 1995	Substantially Equivalent	Olympus America, Inc.
K951694	ELECTRONIC LAPAROFLATOR	Aug 04, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K951961	KSEA MODEL 26012CH ELECTRONIC LAPAROFLATOR	Aug 01, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K941438	OP-PNEU ELECTRONIC CO2	May 11, 1995	Substantially Equivalent	Wisap/U.S.A.
K930013	CO2 INSUFFLATOR 1100	Apr 14, 1995	Substantially Equivalent	Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz
K950219	ENDOLAP INSUFFLATOR TUBING SET	Mar 23, 1995	Substantially Equivalent	Endolap, Inc.
K934115	3000 ELECTRONIC INSUFFLATOR MODIFICATION	Mar 15, 1995	Substantially Equivalent	Cabot Medical Corp.
K945789	DEROYAL DISPOSABLE INSUFFLATION TUBING FILTER	Feb 07, 1995	Substantially Equivalent	Deroyal Industries, Inc.
K944509	DEXIDE INSUFFLATION TUBING WITH FILTER	Feb 07, 1995	Substantially Equivalent	Dexide, Inc.
K934884	MODEL 2231 CO2 INSUFFLATOR	Feb 07, 1995	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K943954	ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER	Nov 15, 1994	Substantially Equivalent	Conmedcorp
K935862	NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL 6600	Aug 19, 1994	Substantially Equivalent	Northgate Technologies, Inc.
K942207	REFLEX INS INSUFFLATION NEEDLE	May 27, 1994	Substantially Equivalent	Richard-Allan Medical
K941685	DISPOSABLE FILTERED INSUFFLATION TUBING SET	May 26, 1994	Substantially Equivalent	Blue Planet Industries, Inc.
K934928	INSITE FILTER & TUBING SET	May 26, 1994	Substantially Equivalent	Andronic Devices, Ltd.
K934926	INSITE MODEL 20 & MODEL 15 INSUFFLATORS	May 26, 1994	Substantially Equivalent	Andronic Devices, Ltd.
K934114	KARL STORZ ELECTRONIC LAPAROFLATOR	May 10, 1994	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K934043	KARL STORZ ELECTRONIC LAPAROFLATOR	May 10, 1994	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K930696	SURE-FLO INSUFFLATION TUBING	Apr 19, 1994	Substantially Equivalent	O.R. Resources, Inc.
K933094	INSUFFLATOR TUBING KIT W/FILTER	Apr 18, 1994	Substantially Equivalent	Inman Medical Corp.
K930767	INSUFO-GARD #100-104	Apr 18, 1994	Substantially Equivalent	Acorn Medical, Inc.
K936155	ADAIR INSUFFLATION AND INSTRUMENTATION CANNULA	Apr 11, 1994	Substantially Equivalent	Micromedical Devices, Inc.
K921756	ELECTRONIC INSUFFLATOR MODEL 2054.61	Mar 28, 1994	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K924481	INSUFFLATION TUBING	Mar 22, 1994	Substantially Equivalent	Applied Medical Resources
K922777	PRESSURE TUBING AND ACCESSORIES	Mar 22, 1994	Substantially Equivalent	Arbor Technologies, Inc.
K935639	INSUFFLATION TUBING STERILE AND NON-STERILE	Mar 17, 1994	Substantially Equivalent	Charles Polo & Co., Inc.
K935503	DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET	Mar 07, 1994	Substantially Equivalent	Davol, Inc.
K934131	DEROYAL SURGICAL DISPOSABLE INSUFFLATION TUBING	Mar 07, 1994	Substantially Equivalent	Deroyal Industries, Inc.
K925558	INFILTUBE	Mar 04, 1994	Substantially Equivalent	Medsurg Industries, Inc.
K930192	VCI INSUFLATOR FILTER W/ TUBING	Mar 02, 1994	Substantially Equivalent	Vital Concepts, Inc.
K920205	OTT INSUFFLATION FILTER TUBING	Oct 25, 1993	Substantially Equivalent	Georgia Biomedical Research Group, Inc.
K923194	INSUFFLATOR CONNECTING FILTER	Oct 08, 1993	Substantially Equivalent	Procedure Products, Inc.
K922244	INSUFFLATOR TUBING/FILTER KIT	Sep 24, 1993	Substantially Equivalent	O.R. Concepts, Inc.
K925691	INSUFFLATION TUBING	Sep 23, 1993	Substantially Equivalent	Mectra Labs, Inc.
K922245	SUPER-FLOW TUBING	Sep 03, 1993	Substantially Equivalent	Armm, Inc.
K921837	MEDICAM 900 INSUFFLATOR WITH ACCESSORIES	Feb 05, 1993	Substantially Equivalent	Kirschner Medical Corp.
K922038	CO2 INSUFFLATION TUBING	Oct 13, 1992	Substantially Equivalent	Surgeon Surgical Instrumentation, Inc.
K921264	SURGIFLATOR	Oct 09, 1992	Substantially Equivalent	W.O.M. World of Medicine GmbH
K913242	MICROPROCESSED CONTROLLED LAPAROFLATOR	Sep 25, 1992	Substantially Equivalent	Bryan Corp.
K921963	DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900	Sep 11, 1992	Substantially Equivalent	Sun Medical, Inc.
K920959	INSUFFLATOR, LAPAROSCOPIC	Jul 13, 1992	Substantially Equivalent	Mectra Labs, Inc.
K915694	MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR	Jun 18, 1992	Substantially Equivalent	Medical Devices, Inc.
K920986	SNOWDEN-PENCER HIGH FLOW INSUFFLATOR, SP/88-9700	Jun 04, 1992	Substantially Equivalent	Snowden-Pencer
K915051	MODIFICATION MODEL 7201 INSUFFLATOR	Jun 04, 1992	Substantially Equivalent	Northgate Technologies, Inc.
K920114	CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR	Apr 06, 1992	Substantially Equivalent	Spiess Design, Inc.
K914153	OTT INSUFFLATOR FILTER PLUS/TUBING SET	Apr 02, 1992	Substantially Equivalent	Marlo Surgical Technology
K913873	SYSTEM 3000 ELECTRONIC INSUFFLATOR	Mar 20, 1992	Substantially Equivalent	Cabot Medical Corp.
K914201	LM- LAP 10 HIGH FLOW INSUFFLATOR	Jan 09, 1992	Substantially Equivalent	Leisegang Medical, Inc.
K910983	IV 1000 INSUFFLATOR RAPID FLOW	Dec 09, 1991	Substantially Equivalent	M.D. Engineering, Inc.
K914403	GENERAL USE KIT #7-510-20	Nov 27, 1991	Substantially Equivalent	Northgate Technologies, Inc.
K914402	RECIRCULATION KIT #7-510-18	Nov 27, 1991	Substantially Equivalent	Northgate Technologies, Inc.
K914401	UNIVERSAL GENERAL USE KIT #7-510-16	Nov 27, 1991	Substantially Equivalent	Northgate Technologies, Inc.
K913979	ENDO I/A Y SET	Nov 27, 1991	Substantially Equivalent	Snowden-Pencer
K914101	CIRCON ACMI CAT.# LAP 9900; HIGH FLOW INSUFFLATOR	Nov 22, 1991	Substantially Equivalent	Circon Video
K913772	PRESSURE GUARD	Nov 19, 1991	Substantially Equivalent	Beacon Laboratories, Inc.
K911179	VERRES NEEDLES 5 & 6 INCHES	Nov 13, 1991	Substantially Equivalent	Northgate Technologies, Inc.
K913835	SNOWDEN-PENCER INSUFFLATOR TUBING SET	Nov 07, 1991	Substantially Equivalent	Snowden-Pencer
K912044	MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR	Jun 24, 1991	Substantially Equivalent	Multigon Industries, Inc.
K911479	LAPAROSCOPIC INSUFLATION Y TUBING	Apr 29, 1991	Substantially Equivalent	United States Endoscopy Group, Inc.
K910883	LAPAROFLATOR ELECTRONIC 3509	Mar 29, 1991	Substantially Equivalent	F.M. Wiest USA, Inc.
K905481	NORTHGATE TECHNOLOGIES MODEL 7201 INSUFFLATOR	Mar 29, 1991	Substantially Equivalent	Northgate Technologies, Inc.
K905705	LAP 3501 HIGH FLOW INSUFFLATOR	Feb 28, 1991	Substantially Equivalent	Circon Acmi
K905549	THE DART	Feb 19, 1991	Substantially Equivalent	Dexide, Inc.
K905417	ELMED PNEUMOMAT DIGITAL	Jan 31, 1991	Substantially Equivalent	Elmed, Inc.
K900808	RAPID AUTOMATIC PNEUMOPERITONEUM-I	Sep 19, 1990	Substantially Equivalent	Trek Medical Products, Inc.
K900878	OTT INSUFFLATION FILTER TUBING	May 07, 1990	Substantially Equivalent	Gynescope Corp.
K882185	ELECTRONIC INSUFFLATOR, MODEL NO. 2054.60	Jun 22, 1988	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K871928	CARBON DIOXIDE INSUFFLATOR/LAPARO & HI FLOW LASER/	Nov 23, 1987	Substantially Equivalent	Medline Industries, Inc.
K845021	MEDICAL DYNAMICS MCCONNELL PRECISION ELEC-INSUFFLA	May 20, 1985	Substantially Equivalent	Medline Industries, Inc.
K812200	INSUFFLATOR	Sep 29, 1981	Substantially Equivalent	Reznik Instruments
K781913	INSUFFALATOR LAPARAOSCOPIC	Dec 04, 1978	Substantially Equivalent	Kli
K772297	INSUFFLATOR, MODEL G100 & 200	Jan 05, 1978	Substantially Equivalent	Kli