OWT — Mesh, Surgical, Absorbable, Abdominal Hernia Class II
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 |