OCWClass II

Endoscopic Tissue Approximation Device

21 CFR 876.1500 / Gastroenterology, Urology

OCW is the FDA product code for Endoscopic Tissue Approximation Device, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue". As of 2026-09-10, FDA records hold 70 510(k) clearances under this code, the most recent dated 2026-02-13, and 4 recalls.

Classification record

Product code: OCW
Device name: Endoscopic Tissue Approximation Device
FDA definition: To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.
Regulation: 21 CFR 876.1500
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 70
Ingested recalls: 4

Clearances, product code OCW

By decision year

70 clearances under product code OCW with a decision year between 1994 and 2026, 1994 the highest year at 9.

Show the numbers

510(k) clearances under FDA product code OCW by decision year
Year	Clearances
1994	9
1995	3
1996	4
1997	3
1998	2
1999	1
2000	3
2001	2
2002	1
2003	4
2006	2
2007	5
2008	4
2009	3
2010	4
2011	1
2012	1
2013	2
2016	2
2017	2
2018	2
2019	1
2020	1
2021	3
2023	3
2025	1
2026	1

Applicants with the most clearances

Product code OCW

Applicants holding the most 510(k) clearances under product code OCW
Applicant	Clearances
Ethicon Endo-Surgery Inc	11
Apollo Endosurgery, Inc.	6
Opus Medical, Inc.	4
Barosense, Inc.	3
Endogastric Solutions, Inc.	3
Mini Lap Technologies, Inc.	3
United States Surgical, A Division of Tyco Healthc	3
ArthroCare Corporation	2
Medtronic, Inc.	2
Covidien Lp, Formerly Registered AS United States	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 43 companies shown, in name order