FDA product code OWT: Mesh, Surgical, Absorbable, Abdominal Hernia
OWT is the FDA product code for mesh, surgical, absorbable, abdominal hernia. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel. FDA has cleared 11 510(k) submissions under OWT, 2 in the last five years, from 6 different applicants. The average 510(k) review took 155 days (median 132); 111 days on average over the last three years.
Definition
For reinforcement of soft tissue where weakness exists during hernia repair.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Absorbable, Abdominal Hernia |
| Device class | Class II |
| Regulation | 21 CFR 878.3300 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for OWT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 272 |
| 2018 | 1 | 208 |
| 2019 | 2 | 80 |
| 2020 | 1 | 269 |
| 2024 | 1 | 90 |
| 2025 | 1 | 132 |
Compare with all 510(k) review times · Search every OWT clearance
Top OWT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| C.R. Bard, Inc. | 4 | 2019-06-12 |
| Novus Scientific AB | 2 | 2020-03-26 |
| W. L. Gore & Associates, Inc. | 2 | 2019-07-31 |
| Davol, Inc., A Subsidiary of C.R. Bard, Inc. | 1 | 2025-02-19 |
| Sofradim Production | 1 | 2024-02-13 |
1 more applicants have OWT clearances. See the full list in Caduvo.
Most recent OWT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243241 | Davol, Inc., A Subsidiary of C.R. Bard, Inc. | Phasix ST Umbilical Hernia Patch | 2025-02-19 | 132 |
| K233661 | Sofradim Production | Transorb Self-Gripping Resorbable Mesh | 2024-02-13 | 90 |
| K191749 | Novus Scientific AB | TIGR Matrix Surgical Mesh, TIGR Surgical Mesh | 2020-03-26 | 269 |
| K191773 | W. L. Gore & Associates, Inc. | GORE BIO-A Tissue Reinforcement | 2019-07-31 | 29 |
| K190185 | C.R. Bard, Inc. | Phasix ST Mesh with Open Positioning System | 2019-06-12 | 131 |
Recalls for OWT devices
openFDA lists no recalls for product code OWT.
Frequently asked questions
What is FDA product code OWT?
OWT is the FDA product code for mesh, surgical, absorbable, abdominal hernia. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel.
What device class is OWT?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code OWT?
Across 11 cleared submissions the average was 155 days from receipt to decision (median 132).
Which companies have the most OWT clearances?
C.R. Bard, Inc. (4); Novus Scientific AB (2); W. L. Gore & Associates, Inc. (2); Davol, Inc., A Subsidiary of C.R. Bard, Inc. (1); Sofradim Production (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OWT
- Run a recall and safety report across every OWT manufacturer
- Watch product code OWT 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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