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 United States Surgical, A Division of Tyco Healthc, Apollo Endosurgery and Apollo Endosurgery, Inc..

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 Mar 30, 2000
SMITH & NEPHEW SUTURELOK, MODEL 7207321
K000717
Smith & Nephew, Inc.
Gastroenterology & Urology · 27d
Cleared Nov 27, 1996
AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE
K963999
United States Surgical, A Division of Tyco Healthc
Gastroenterology & Urology · 51d
Cleared Feb 21, 1996
ENDOSCOPIC NEEDLE DRIVER
K960011
United States Surgical, A Division of Tyco Healthc
Gastroenterology & Urology · 50d
Cleared Dec 08, 1995
KOH MICRO-SUTURING INSTRUMENTS
K955479
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 8d
Cleared Mar 16, 1994
AUTOSUTURE ENDOSCOPIC SUTURING DEVICE
K934738
United States Surgical, A Division of Tyco Healthc
Gastroenterology & Urology · 166d

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 →