Product Code: FED FDA class 2 21 CFR 876.1500

Endoscopic Access Overtube, Gastroenterology-Urology

Gastroenterology, Urology

The Endoscopic Access Overtube for Gastroenterology-Urology (product code FED) is a tubular sleeve placed over an endoscope to facilitate its passage and advancement into the body, particularly useful in cases requiring repeated intubation or difficult access. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. No special flags apply.

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510(k)s

101

FEI Numbers

116

Registration Numbers

116

Unique Applicants

Years Active

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Basic Information

Product Code: FED
Device Class: FDA class 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Definition

To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 101 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260965	CVAC Aspiration System	Apr 13, 2026	Substantially Equivalent	Calyxo, Inc.
K260521	ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)	Apr 06, 2026	Substantially Equivalent	Zhuhai Pusen Medical Technology Co., Ltd.
K252572	Prodeon Urethral Sheath System	Oct 07, 2025	Substantially Equivalent	Prodeon Medical, Inc.
K250128	Single Use Suction-Evacuation Ureteral Access Sheath	Sep 19, 2025	Substantially Equivalent	Anhui Happiness Workshop Medical Instruments Co., Ltd.
K250132	Ureteral Access Sheath	Sep 05, 2025	Substantially Equivalent	Zhejiang YiGao Medical Technology Co., Ltd.
K250695	Single-use Ureteral Access Sheath	Jul 08, 2025	Substantially Equivalent	Shenzhen HugeMed Medical Technical Development Co., Ltd.
K251599	Single-use Ureteral Access Sheath	Jul 03, 2025	Substantially Equivalent	Hunan Vathin Medical Instrument Co., Ltd.
K250585	LumenaTM Ureteral Access Sheath	Jun 27, 2025	Substantially Equivalent	Cathegenix (Xiamen) Co., Ltd.
K250452	CoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B)	Jun 02, 2025	Substantially Equivalent	MacroLux Medical Technology Co., Ltd.
K243710	Disposable ureteral access sheath	Apr 11, 2025	Substantially Equivalent	Shenzhen Trious Medical Technology Co., Ltd.
K250517	Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator HD Ureteral Access Sheath Set 13/15 F x 28cm (M006	Mar 21, 2025	Substantially Equivalent	Boston Scientific Corporation
K243820	Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250	Jan 31, 2025	Substantially Equivalent	Dornier Medtech America
K243025	Ureteral Access Sheath	Jan 30, 2025	Substantially Equivalent	Seplou (Zhuhai) Co., Ltd.
K242173	Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)	Nov 12, 2024	Substantially Equivalent	Coloplast Corp.
K243091	Over-tube (TR-1108A)	Nov 01, 2024	Substantially Equivalent	Fujifilm Corporation
K240167	Single-use Ureteral Access Sheath	Oct 08, 2024	Substantially Equivalent	Hunan Vathin Medical Instrument Co., Ltd.
K241181	Disposable Ureteral Guide Sheath	Aug 02, 2024	Substantially Equivalent	Dongguan Zsr Biomedical Technology Company Limited
K240853	Pathfinder® CR System	Jun 27, 2024	Unknown	Neptune Medical, Inc.
K233472	CVAC Aspiration System + CVAC Image Processor	Feb 02, 2024	Substantially Equivalent	Calyxo, Inc.
K230752	Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)	Sep 15, 2023	Substantially Equivalent	FUJIFILM Healthcare Americas Corporation
K230748	Disposable Ureteral Access Sheath	Aug 02, 2023	Substantially Equivalent	Youcare Technology Co.,Ltd. (Wuhan)
K230801	Pathfinder Endoscope Overtube with Balloon Device	Jul 28, 2023	Substantially Equivalent	Neptune Medical, Inc.
K220065	Single Use Ureteral Access Sheath	May 25, 2022	Substantially Equivalent	Zhejiang Chuangxiang Medical Technology Co., Ltd.
K200770	Mini PCNL-System	Jul 30, 2021	Substantially Equivalent	Trokamed GmbH
K211301	Pathfinder Endoscope Overtube	May 28, 2021	Substantially Equivalent	Neptune Medical, Inc.
K203165	Disposable Ureteral Access Sheath	Apr 30, 2021	Substantially Equivalent	Suzhou Beyo Medical Technology Co., Ltd.
K203119	ClearPetra Suction-Evacuation Sheath	Dec 09, 2020	Substantially Equivalent	Well Lead Medical Co., Ltd.
K201815	Dornier MAGELLAN Ureteral Access Sheath	Nov 20, 2020	Substantially Equivalent	Dornier Medtech America, Inc.
K200419	Kalera Vacuum Aspiration Catheter (K-VAC)	May 22, 2020	Substantially Equivalent	Kalera Medical, Inc.
K192691	PatCom Single-Use Introducer	Feb 21, 2020	Substantially Equivalent	H&A Mui Enterprises, Inc.
K191415	Pathfinder Endoscope Overtube	Aug 30, 2019	Substantially Equivalent	Neptune Medical, Inc.
K191067	Arc Endocuff Glide AEG110 & AEG120	May 30, 2019	Substantially Equivalent	Boddingtons Plastics, Ltd.
K182403	Peel-Away Introducer	May 29, 2019	Substantially Equivalent	Cook Incorporated
K182520	Flexible Overtube	May 15, 2019	Substantially Equivalent	Sumitomo Bakelite Co., Ltd.
K190030	Embrella Endoscopic Distal Attachment	Mar 05, 2019	Substantially Equivalent	Micro-Tech (Nanjing) Co., Ltd.
K181811	ReTrace Ureteral Access Sheath	Sep 07, 2018	Substantially Equivalent	Coloplast A/S
K173400	ORISE Tissue Retractor System	Feb 09, 2018	Substantially Equivalent	Boston Scientific
K171208	Trans-anal Introducer	Feb 05, 2018	Substantially Equivalent	Visionsense, Ltd.
K172575	BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap	Jan 18, 2018	Substantially Equivalent	Baronova, Inc.
K172217	Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath	Dec 13, 2017	Substantially Equivalent	Cook Incorporated
K162205	Arc EndoCuff and Arc EndoCuff Vision	Dec 09, 2016	Substantially Equivalent	Boddingtons Plastics, Ltd.
K161110	ClearPetra Suction-Evacuation Sheath	Oct 12, 2016	Substantially Equivalent	Well Lead Medical Co., Ltd.
K160846	AmplifEYE	Jul 14, 2016	Substantially Equivalent	Medivators, Inc.
K160861	Proxis Ureteral Access Sheath	Mar 31, 2016	Substantially Equivalent	C.R. Bard, Inc.
K151084	Well Lead Ureteral Access Sheath	Jan 07, 2016	Substantially Equivalent	Well Lead Medical Co., Ltd.
K151801	Arc Endocuff Vision	Aug 13, 2015	Substantially Equivalent	Boddingtons Plastics, Ltd.
K150083	Sidecar External Working Channel	Apr 14, 2015	Substantially Equivalent	C2 Therapeutics
K140523	RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM	Jul 24, 2014	Substantially Equivalent	Coloplast A/S
K140323	NAVIGATOR HD URETERAL ACCESS SHEATH SETS	Mar 07, 2014	Substantially Equivalent	Boston Scientific
K131598	ANAL RECTAL OVERTUBE	Feb 26, 2014	Substantially Equivalent	United States Endoscopy Group, Inc.
K133359	ENDORINGS	Feb 11, 2014	Substantially Equivalent	Endo-Aid, Inc.
K123013	ENDOSCOPIC INTRODUCER	Mar 22, 2013	Substantially Equivalent	Novadaq Technologies, Inc.
K123675	RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR	Mar 01, 2013	Substantially Equivalent	Coloplast A/S
K122649	NAVIGATOR HD URETERAL ACCESS SHEATH SET	Dec 12, 2012	Substantially Equivalent	Boston Scientific Corp
K122270	OVERTUBE ENDOSCOPIC ACCESS SYSTEM	Sep 28, 2012	Substantially Equivalent	Apollo Endosurgery, Inc.
K120126	BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE	Sep 10, 2012	Substantially Equivalent	Barosense, Inc.
K122565	ARC ENDOCUFF	Sep 04, 2012	Substantially Equivalent	Boddingtons Plastics, Ltd.
K110531	ENDOFLIP ECD	Oct 06, 2011	Substantially Equivalent	Crospon, Ltd.
K102485	RE-TRACE URETERAL ACCESS SHEATH	Oct 18, 2010	Substantially Equivalent	Coloplast A/S
K082102	GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00	Jun 14, 2010	Unknown	Apollo Endosurgery, Inc.
K100081	ENTEROSCOPY OVERTUBE, MODEL 00712140	Apr 12, 2010	Substantially Equivalent	United States Endoscopy Group, Inc.
K092221	COLONIC SPLINTING OVERTUBE, MODEL 00711145	Oct 20, 2009	Substantially Equivalent	United States Endoscopy Group, Inc.
K092156	CAD 12, COLONOSCOPY ASSIST DEVICE	Oct 14, 2009	Substantially Equivalent	Softscope Medical Technologies, Inc.
K091773	FUJINON STERILE OVERTUBES	Aug 07, 2009	Substantially Equivalent	Fujinon, Inc.
K082589	BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034	May 22, 2009	Substantially Equivalent	Barosense, Inc.
K080050	SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE	May 06, 2008	Substantially Equivalent	Spirus Medical, Inc.
K072405	USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE	Sep 13, 2007	Substantially Equivalent	Usgi Medical
K062805	MODIFICATION TO ENDO-EASE	Oct 13, 2006	Substantially Equivalent	Spirus Medical, Inc.
K061324	EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7	Jun 20, 2006	Substantially Equivalent	Rtc Inc.-Memcath Technologies, LLC
K061216	USGI TRANSPORT ENDOSCOPIC GUIDE	May 15, 2006	Substantially Equivalent	Usgi Medical
K052084	ENDO-EASE ENDOSCOPIC OVERTUBE	Sep 14, 2005	Substantially Equivalent	Spirus Medical, Inc.
K051919	MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE	Jul 26, 2005	Substantially Equivalent	Usgi Medical
K051504	SPYSCOPE ACCESS AND DELIVERY CATHETER	Jun 16, 2005	Substantially Equivalent	Boston Scientific Corp
K043418	COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH	Mar 31, 2005	Substantially Equivalent	Cook Urological, Inc.
K050253	USGI SHAPELOCK ENDOSCOPIC GUIDE	Feb 28, 2005	Substantially Equivalent	Usgi Medical
K040836	DISPOSABLE OVERTUBE	Jun 10, 2004	Substantially Equivalent	United States Endoscopy Group, Inc.
K033954	SHAPE LOCKING ENDOSCOPIC OVERTUBE	Mar 19, 2004	Substantially Equivalent	Usgi Medical, Inc.
K033778	MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT	Dec 30, 2003	Substantially Equivalent	C.R. Bard, Inc.
K023902	SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE	Aug 20, 2003	Substantially Equivalent	Usgi Medical, Inc.
K030956	NAVIGATOR URETERAL ACCESS SHEATH SET	May 23, 2003	Substantially Equivalent	Boston Scientific Corp
K030642	DEFLECTING URETERAL ACCESS SHEATH	May 23, 2003	Substantially Equivalent	Applied Medical Resources Corp.
K030438	BARD AQUAGUIDE URETERAL CONDUIT	Mar 17, 2003	Substantially Equivalent	C.R. Bard, Inc.
K022686	LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE	Nov 25, 2002	Substantially Equivalent	Lap Surgical Systems, LLC
K002018	NDO SURGICAL SURGICAL OVERTUBE	Aug 17, 2000	Substantially Equivalent	Surgical, Inc.
K993650	URETERAL ACCESS SHEATH SET - NEW MODELS	Dec 28, 1999	Substantially Equivalent	Applied Medical Resources
K990775	URETERAL ACCESS SHEATH SET	Apr 21, 1999	Substantially Equivalent	Applied Medical Resources
K983415	DELIVERY SHEATH	Dec 01, 1998	Substantially Equivalent	Conway Stuart Medical, Inc.
K973500	BARD ENDOSCOPIC OVERTUBE (#000307)	Oct 16, 1997	Substantially Equivalent	C.R. Bard, Inc.
K972781	OT-1	Sep 19, 1997	Substantially Equivalent	Prism Therapeutics, LLC
K942573	COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH	Jul 18, 1994	Substantially Equivalent	Richard Hamer Assoc., Inc.
K942044	BARD ENDOSCOPIC OVERTUBE	Jun 10, 1994	Substantially Equivalent	C.R. Bard, Inc.
K921120	FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER	Aug 04, 1992	Substantially Equivalent	Cook Urological, Inc.
K912265	MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000	Oct 10, 1991	Substantially Equivalent	Medical Laser, Inc.
K903842	ST-E1 OVERTUBE	Jan 23, 1991	Substantially Equivalent	Olympus Corp.
K896680	PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC.	Feb 14, 1990	Substantially Equivalent	Interson Corp.
K890629	ESOPHAGEAL OVERTUBE	May 31, 1989	Substantially Equivalent	Gastrotech, Inc.
K841258	FOREIGN BODY PROTECTOR	Jul 09, 1984	Substantially Equivalent	Jayco Pharmaceuticals
K833268	ENDOSCOPIC OVERTUBE	Oct 31, 1983	Substantially Equivalent	Mill-Rose Laboratory
K830247	SPLIT COLON STIFFENING TUBE	Mar 15, 1983	Substantially Equivalent	Keymed, Inc.
K813325	KEY MED FOREIGN BODY REMOVAL TUBE	Feb 10, 1982	Substantially Equivalent	Keymed, Inc.
K810180	WILLIAMS OESOPHAGEAL VARICES INJECT TUBE	Feb 09, 1981	Substantially Equivalent	Keymed, Inc.