Product Code: OCW FDA class 2 21 CFR 876.1500

Endoscopic Tissue Approximation Device

Gastroenterology, Urology

The Endoscopic Tissue Approximation Device (product code OCW) is a gastroenterology and urology device used to aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue during minimally invasive GI and GU procedures. Tissue approximation is used for wound closure, hemostasis, and anatomical repair within body cavities. This device is FDA Class 2 under regulation 876.1500 in the Gastroenterology, Urology specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: OCW
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

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Summary Malfunction Reporting

Definition

To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 70 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252400	Endomina EZFuse system	Feb 13, 2026	Substantially Equivalent	Endo Tools Therapeutics S.A.
K243750	SimpleStitch Suturing System	Apr 17, 2025	Substantially Equivalent	Envision Endoscopy
K231240	MaxTack Motorized Fixation Device	Sep 08, 2023	Substantially Equivalent	Covidien
K213271	MedicloseTM System	Aug 31, 2023	Substantially Equivalent	Health Value Creation B.V., Trading AS Corporis Medical
K231553	OverStitch NXT Endoscopic Suturing System	Jun 29, 2023	Substantially Equivalent	Apollo Endosurgery, Inc.
K211309	endomina system	Dec 07, 2021	Substantially Equivalent	Endo Tools Therapeutics S.A.
K201744	Su2ura Approximation Device	Jun 17, 2021	Substantially Equivalent	Anchora Medical, Ltd.
K210266	OverStitch Sx Endoscopic Suturing System	Mar 02, 2021	Substantially Equivalent	Apollo Endosurgery, Inc.
K193652	AbClose - Port Site Closure Device	Mar 26, 2020	Substantially Equivalent	Medeon Biodesign, Inc.
K191439	OverStitch 2-0 Polypropylene Suture	Aug 29, 2019	Substantially Equivalent	Apollo Endosurgery
K181141	OverStitch Endoscopic Suturing System and Accessories	Jun 27, 2018	Substantially Equivalent	Apollo Endosurgery
K172775	MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle	Feb 12, 2018	Substantially Equivalent	Teleflexmedical, Inc.
K172666	CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor	Dec 01, 2017	Substantially Equivalent	Sutureease, Inc.
K171886	OverStitch SX Endoscopic Suturing System (ESS)	Nov 15, 2017	Substantially Equivalent	Apollo Endosurgery, Inc.
K160117	AbClose - Port Site Closure Device	Sep 09, 2016	Substantially Equivalent	Medeon Biodesign, Inc.
K160149	Miret Grasper, Alligator, Miret Grasper, Maryland	Aug 30, 2016	Substantially Equivalent	Miret Surgical, Inc.
K132232	MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM	Dec 04, 2013	Substantially Equivalent	Minilap Technologies
K132362	WECK EFX ENDO FASCIAL CLOSURE SYSTEM	Oct 08, 2013	Substantially Equivalent	Teleflexmedical, Inc.
K120147	ACE STAPLER AND CARTRIDGE	Feb 17, 2012	Substantially Equivalent	Barosense, Inc.
K110829	ACE STAPLER AND CARTRIDGE	Jun 03, 2011	Substantially Equivalent	Barosense, Inc.
K103412	AXIOM FASCIAL CLOSURE SYSTEM	Dec 30, 2010	Substantially Equivalent	Axiom Technology Partners, LLC
K102931	G-CINCH SUTURE GRASPER	Dec 30, 2010	Substantially Equivalent	Usgi Medical
K101101	MINI-TONG	Jul 23, 2010	Substantially Equivalent	Mini Lap Technologies, Inc.
K082044	ACE STAPLER, MODEL F0031	May 11, 2010	Substantially Equivalent	Barosense, Inc.
K091832	ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER	Jul 22, 2009	Substantially Equivalent	Endogastric Solutions, Inc.
K090470	AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES	May 14, 2009	Substantially Equivalent	Covidien
K090419	SILS STITCH ENDOSCOPIC SUTURING DEVICE	Mar 09, 2009	Substantially Equivalent	Covidien Lp, Formerly Registered AS United States
K082659	MODIFIED ENDO STICH	Sep 19, 2008	Substantially Equivalent	Covidien Lp, Formerly Registered AS United States
K081853	OVERSTITCH ENDOSCOPIC SUTURE SYSTEM	Aug 18, 2008	Substantially Equivalent	Apollo Endosurgery, Inc.
K073644	ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES	Jun 27, 2008	Substantially Equivalent	Endogastric Solutions, Inc.
K073671	PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE	Mar 26, 2008	Substantially Equivalent	Ndo Surgical, Inc.
K070151	INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER	Aug 15, 2007	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K070671	OPUS SMARTSTITCH SUTURE DEVICE	Apr 06, 2007	Substantially Equivalent	Arthrocare Corp.
K070686	MINI LAP INSTRUMENTS	Apr 05, 2007	Substantially Equivalent	Mini Lap Technologies, Inc.
K070352	MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM	Apr 05, 2007	Substantially Equivalent	Mini Lap Technologies, Inc.
K062875	ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES	Mar 09, 2007	Substantially Equivalent	Endogastric Solutions, Inc.
K062244	OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR	Oct 02, 2006	Substantially Equivalent	Arthrocare Corp.
K061770	ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM	Sep 25, 2006	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K033317	SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070	Dec 30, 2003	Substantially Equivalent	Opus Medical, Inc.
K033269	ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD	Dec 10, 2003	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K030170	REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500	Jul 28, 2003	Substantially Equivalent	Opus Medical, Inc.
K023843	SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE	Feb 14, 2003	Substantially Equivalent	Opus Medical, Inc.
K022229	SMARTSTITCH SUTURE DEVICE, MODEL OM-8500	Sep 06, 2002	Substantially Equivalent	Opus Medical, Inc.
K003949	TACKER, MODEL R65-933	Jul 25, 2001	Substantially Equivalent	A & A Medical, Inc.
K003102	PARE ENDOSCOPIC SUTURING SYSTEM	Feb 27, 2001	Substantially Equivalent	Pare Surgical, Inc.
K002398	ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING	Nov 03, 2000	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K000717	SMITH & NEPHEW SUTURELOK, MODEL 7207321	Mar 30, 2000	Substantially Equivalent	Smith & Nephew, Inc.
K994087	SUPERSTITCH	Mar 01, 2000	Substantially Equivalent	Sutura, Inc.
K991500	SMITH & NEPHEW SUTURE LOK	Jul 14, 1999	Substantially Equivalent	Smith & Nephew Endoscopy, Inc.
K980815	ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER	May 01, 1998	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K974137	UROMED NEEDLE GRASPER	Jan 30, 1998	Substantially Equivalent	Uromed Corp.
K973313	INNOVASIVE DEVICES Y-KNOT SUTURE CLIP	Dec 01, 1997	Substantially Equivalent	Innovasive Devices, Inc.
K971939	SMITH & NEPHEW SUTURE COLLET	Aug 06, 1997	Substantially Equivalent	Smith & Nephew Endoscopy, Inc.
K970720	ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER AND THE ENDOPATH EZ45 NO KNIFE ENDOSCOPIC LINEAR STAPLER	Jun 27, 1997	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K963999	AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE	Nov 27, 1996	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K962493	ENDOSCOPIC CLIP APPLIER	Sep 11, 1996	Substantially Equivalent	Aesculap, Inc.
K961390	ENDOPATH ETS LINEAR/ETS-FLEX ARTICULATING LINEAR ENDOSCOPIC CUTTER	Jun 25, 1996	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K960011	ENDOSCOPIC NEEDLE DRIVER	Feb 21, 1996	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K954641	ENDO-LEADER	Dec 28, 1995	Substantially Equivalent	Microsurge, Inc.
K955479	KOH MICRO-SUTURING INSTRUMENTS	Dec 08, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K945202	ENDOPATH ENDOSCOPIC RELOADABLE LINEAR CUTTER WITH SAFETY LOC-OUT AND RELOADING UNIT	Jan 19, 1995	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K944415	ORIGIN TACKER SYSTEM	Nov 28, 1994	Substantially Equivalent	Origin Medsystems, Inc.
K944435	DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER	Nov 15, 1994	Substantially Equivalent	Deroyal Industries, Inc.
K944292	SURGICAL INNOVATIONS DISPOSABLE ENDOSCOPIC HERNIA SURGICAL STAPLER SURGICAL INNOVATIONS RESUABLE SURGICAL STAPLER HANDLE	Nov 15, 1994	Substantially Equivalent	Surgical Innovations Corp.
K940967	MODIFIED ENDOPATH ILS	May 27, 1994	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K935756	ENDOSCOPIC ARTICULATING MULTI-FEED STAPLER WITH RELOAD UNIT	Apr 21, 1994	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K934738	AUTOSUTURE ENDOSCOPIC SUTURING DEVICE	Mar 16, 1994	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K934174	LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER	Mar 09, 1994	Substantially Equivalent	ETHICON, Inc.
K932434	PROXIMATE ARTICULATING LINEAR STAPLER	Feb 07, 1994	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K935064	ENDOPATH ENDOSCOPIC LINEAR CUTTER MODIFICATION	Jan 03, 1994	Substantially Equivalent	ETHICON, Inc.