OCW · Class II · 21 CFR 876.1500

FDA Product Code OCW: Endoscopic Tissue Approximation Device

To Aid In Endoscopically Placing Sutures, Staples, Clips, And Other Fastening Tools Through Tissue.

Leading manufacturers include Ethicon Endo-Surgery, Inc., United States Surgical, A Division of Tyco Healthc and Arthrocare Corp..

70
Total
70
Cleared
118d
Avg days
1994
Since
Declining activity - 2 submissions in the last 2 years vs 3 in the prior period
Review times increasing: avg 165d recently vs 117d historically

FDA 510(k) Cleared Endoscopic Tissue Approximation Device Devices (Product Code OCW)

70 devices
1–24 of 70
Cleared Feb 13, 2026
Endomina EZFuse system
K252400
Endo Tools Therapeutics S.A.
Gastroenterology & Urology · 197d
Cleared Apr 17, 2025
SimpleStitch Suturing System
K243750
Envision Endoscopy
Gastroenterology & Urology · 133d
Cleared Sep 08, 2023
MaxTack™ Motorized Fixation Device
K231240
Covidien
General & Plastic Surgery · 133d
Cleared Aug 31, 2023
MedicloseTM System
K213271
Health Value Creation B.V., Trading AS Corporis Medical
General & Plastic Surgery · 700d
Cleared Jun 29, 2023
OverStitch NXT Endoscopic Suturing System
K231553
Apollo Endosurgery, Inc.
General & Plastic Surgery · 30d
Cleared Dec 07, 2021
endomina system
K211309
Endo Tools Therapeutics S.A.
Gastroenterology & Urology · 221d
Cleared Jun 17, 2021
Su2ura Approximation Device
K201744
Anchora Medical, Ltd.
General & Plastic Surgery · 357d
Cleared Mar 02, 2021
OverStitch Sx Endoscopic Suturing System
K210266
Apollo Endosurgery, Inc.
General & Plastic Surgery · 29d
Cleared Mar 26, 2020
AbClose - Port Site Closure Device
K193652
Medeon Biodesign, Inc.
General & Plastic Surgery · 87d
Cleared Aug 29, 2019
OverStitch 2-0 Polypropylene Suture
K191439
Apollo Endosurgery
General & Plastic Surgery · 91d
Cleared Jun 27, 2018
OverStitch Endoscopic Suturing System and Accessories
K181141
Apollo Endosurgery
Gastroenterology & Urology · 57d
Cleared Feb 12, 2018
MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
K172775
Teleflexmedical, Inc.
Gastroenterology & Urology · 151d
Cleared Oct 08, 2013
WECK EFX ENDO FASCIAL CLOSURE SYSTEM
K132362
Teleflexmedical, Inc.
General & Plastic Surgery · 70d
Cleared May 14, 2009
AUTOSUTURE PROTACK
K090470
Covidien
General & Plastic Surgery · 80d
Cleared Aug 15, 2007
INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER
K070151
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 211d
Cleared Apr 06, 2007
OPUS SMARTSTITCH SUTURE DEVICE
K070671
Arthrocare Corp.
Gastroenterology & Urology · 25d
Cleared Oct 02, 2006
OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR
K062244
Arthrocare Corp.
Gastroenterology & Urology · 60d
Cleared Sep 25, 2006
ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM
K061770
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 94d
Cleared Dec 10, 2003
ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD
K033269
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 62d
Cleared Nov 03, 2000
ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING
K002398
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 88d
Cleared Mar 30, 2000
SMITH & NEPHEW SUTURELOK, MODEL 7207321
K000717
Smith & Nephew, Inc.
Gastroenterology & Urology · 27d
Cleared May 01, 1998
ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER
K980815
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 59d
Cleared Jun 27, 1997
ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER AND THE ENDOPATH EZ45 NO KNIFE ENDOSCOPIC LINEAR STAPLER
K970720
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 120d
Cleared Nov 27, 1996
AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE
K963999
United States Surgical, A Division of Tyco Healthc
Gastroenterology & Urology · 51d

About Product Code OCW - Regulatory Context

510(k) Submission Activity

70 total 510(k) submissions under product code OCW since 1994, with 70 receiving FDA clearance (average review time: 118 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - OCW Product Code

Recent submissions under OCW have taken an average of 165 days to reach a decision - up from 117 days historically. Manufacturers should account for longer review timelines in current project planning.

OCW devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →