OWT
- Product code
- OWT
- Device name
- Mesh, Surgical, Absorbable, Abdominal Hernia
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.3300
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 11
FDA classification definition
For reinforcement of soft tissue where weakness exists during hernia repair.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243241 | 2025-02-19 | Davol, Inc., A Subsidiary of C.R. Bard | Phasix ST Umbilical Hernia Patch | |
| K233661 | 2024-02-13 | Sofradim Production | Transorb Self-Gripping Resorbable Mesh |
Official FDA classification page: OWT
Classification and pathway per current FDA publications. Data from openFDA (CC0).