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 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
Cleared
Feb 13, 2026
Endomina EZFuse system
Endo Tools Therapeutics S.A.
Gastroenterology & Urology
197d
Cleared
Apr 17, 2025
SimpleStitch Suturing System
Envision Endoscopy
Gastroenterology & Urology
133d
Cleared
Sep 08, 2023
MaxTack™ Motorized Fixation Device
Covidien
General & Plastic Surgery
133d
Cleared
Aug 31, 2023
MedicloseTM System
Health Value Creation B.V., Trading AS Corporis Medical
General & Plastic Surgery
700d
Cleared
Jun 29, 2023
OverStitch NXT Endoscopic Suturing System
Apollo Endosurgery, Inc.
General & Plastic Surgery
30d
Cleared
Dec 07, 2021
endomina system
Endo Tools Therapeutics S.A.
Gastroenterology & Urology
221d
Cleared
Jun 17, 2021
Su2ura Approximation Device
Anchora Medical, Ltd.
General & Plastic Surgery
357d
Cleared
Mar 02, 2021
OverStitch Sx Endoscopic Suturing System
Apollo Endosurgery, Inc.
General & Plastic Surgery
29d
Cleared
Mar 26, 2020
AbClose - Port Site Closure Device
Medeon Biodesign, Inc.
General & Plastic Surgery
87d
Cleared
Aug 29, 2019
OverStitch 2-0 Polypropylene Suture
Apollo Endosurgery
General & Plastic Surgery
91d
Cleared
Jun 27, 2018
OverStitch Endoscopic Suturing System and Accessories
Apollo Endosurgery
Gastroenterology & Urology
57d
Cleared
Feb 12, 2018
MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
Teleflexmedical, Inc.
Gastroenterology & Urology
151d
Cleared
Dec 01, 2017
CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor
Sutureease, Inc.
General & Plastic Surgery
87d
Cleared
Nov 15, 2017
OverStitch SX Endoscopic Suturing System (ESS)
Apollo Endosurgery, Inc.
General & Plastic Surgery
142d
Cleared
Sep 09, 2016
AbClose - Port Site Closure Device
Medeon Biodesign, Inc.
General & Plastic Surgery
234d
Cleared
Aug 30, 2016
Miret Grasper, Alligator, Miret Grasper, Maryland
Miret Surgical, Inc.
Gastroenterology & Urology
222d
Cleared
Dec 04, 2013
MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM
Minilap Technologies
Gastroenterology & Urology
139d
Cleared
Oct 08, 2013
WECK EFX ENDO FASCIAL CLOSURE SYSTEM
Teleflexmedical, Inc.
General & Plastic Surgery
70d
Cleared
Feb 17, 2012
ACE STAPLER AND CARTRIDGE
Barosense, Inc.
Gastroenterology & Urology
30d
Cleared
Jun 03, 2011
ACE STAPLER AND CARTRIDGE
Barosense, Inc.
Gastroenterology & Urology
71d
Cleared
Dec 30, 2010
AXIOM FASCIAL CLOSURE SYSTEM
Axiom Technology Partners, LLC
General & Plastic Surgery
38d
Cleared
May 14, 2009
AUTOSUTURE PROTACK
Covidien
General & Plastic Surgery
80d
Cleared
Aug 15, 2007
INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER
Ethicon Endo-Surgery, LLC
General & Plastic Surgery
211d
Cleared
Apr 06, 2007
OPUS SMARTSTITCH SUTURE DEVICE
Arthrocare Corp.
Gastroenterology & Urology
25d
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 →