FDA product code OCW: Endoscopic Tissue Approximation Device
OCW is the FDA product code for endoscopic tissue approximation device. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 70 510(k) submissions under OCW, 5 in the last five years, from 38 different applicants. The average 510(k) review took 118 days (median 86); 165 days on average over the last three years. FDA has posted 4 recalls for OCW devices, 4 initiated in the last five years.
Definition
To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Tissue Approximation Device |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for OCW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 114 |
| 2018 | 2 | 104 |
| 2019 | 1 | 91 |
| 2020 | 1 | 87 |
| 2021 | 3 | 202 |
| 2023 | 3 | 288 |
| 2025 | 1 | 133 |
| 2026 | 1 | 197 |
Compare with all 510(k) review times · Search every OCW clearance
Top OCW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ethicon Endo-Surgery, Inc. | 10 | 2006-09-25 |
| Apollo Endosurgery, Inc. | 4 | 2023-06-29 |
| Opus Medical, Inc. | 4 | 2003-12-30 |
| Barosense, Inc. | 3 | 2012-02-17 |
| Mini Lap Technologies, Inc. | 3 | 2010-07-23 |
33 more applicants have OCW clearances. See the full list in Caduvo.
Most recent OCW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252400 | Endo Tools Therapeutics S.A. | Endomina EZFuse system | 2026-02-13 | 197 |
| K243750 | Envision Endoscopy | SimpleStitch Suturing System | 2025-04-17 | 133 |
| K231240 | Covidien | MaxTack Motorized Fixation Device | 2023-09-08 | 133 |
| K213271 | Health Value Creation B.V., Trading AS Corporis Medical | MedicloseTM System | 2023-08-31 | 700 |
| K231553 | Apollo Endosurgery, Inc. | OverStitch NXT Endoscopic Suturing System | 2023-06-29 | 30 |
Recalls for OCW devices
4 product recalls in 3 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-07-14.
| Year | Recalls |
|---|---|
| 2023 | 1 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code OCW?
OCW is the FDA product code for endoscopic tissue approximation device. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is OCW?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code OCW?
Across 70 cleared submissions the average was 118 days from receipt to decision (median 86).
Which companies have the most OCW clearances?
Ethicon Endo-Surgery, Inc. (10); Apollo Endosurgery, Inc. (4); Opus Medical, Inc. (4); Barosense, Inc. (3); Mini Lap Technologies, Inc. (3).
Have OCW devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2026-07-14.
Next steps
- Run an FDA pathway report with predicate devices for product code OCW
- Run a recall and safety report across every OCW manufacturer
- Watch product code OCW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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