OWT — Mesh, Surgical, Absorbable, Abdominal Hernia Class II
FDA product code OWT covers "Mesh, Surgical, Absorbable, Abdominal Hernia", a Class II medical device regulated under 21 CFR 878.3300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OWT
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
For reinforcement of soft tissue where weakness exists during hernia repair.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243241 | davol, inc., a subsidiary of c.r. bard | Phasix ST Umbilical Hernia Patch | February 19, 2025 |
| K233661 | sofradim production | Transorb Self-Gripping Resorbable Mesh | February 13, 2024 |
| K191749 | novus scientific | TIGR Matrix Surgical Mesh, TIGR Surgical Mesh | March 26, 2020 |
| K191773 | w. l. gore and associates | GORE BIO-A Tissue Reinforcement | July 31, 2019 |
| K190185 | c.r. bard | Phasix ST Mesh with Open Positioning System | June 12, 2019 |
| K173143 | c.r. bard | Phasix ST Mesh | April 25, 2018 |
| K163005 | novus scientific | TIGR Matrix Surgical Mesh | July 27, 2017 |
| K143380 | c.r. bard | Phasix ST Mesh | June 5, 2015 |
| K120728 | c.r. bard | PHASIX PLUG AND PATCH | October 22, 2012 |
| K101287 | tepha | TEPHAFLEX COMPOSITE MESH | August 30, 2010 |
| K033671 | w. l. gore and associates | GORE BIOABSORBABLE MESH | December 31, 2003 |