OWT · Mesh, Surgical, Absorbable, Abdominal Hernia
General, Plastic Surgery · 21 CFR 878.3300 · Class 2
Overview
| Product Code | OWT |
|---|---|
| Device Name | Mesh, Surgical, Absorbable, Abdominal Hernia |
| Regulation | 21 CFR 878.3300 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.
Classification Rationale
Class II.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243241 | Phasix ST Umbilical Hernia Patch | Davol, Inc., A Subsidiary of C.R. Bard, Inc. | Feb 19, 2025 | SESE |
| K233661 | Transorb Self-Gripping Resorbable Mesh | Sofradim Production | Feb 13, 2024 | SESE |
| K191749 | TIGR Matrix Surgical Mesh, TIGR Surgical Mesh | Novus Scientific AB | Mar 26, 2020 | SESE |
| K191773 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | Jul 31, 2019 | SESE |
| K190185 | Phasix ST Mesh with Open Positioning System | C.R. Bard, Inc. | Jun 12, 2019 | SESE |
| K173143 | Phasix ST Mesh | C.R. Bard, Inc. | Apr 25, 2018 | SESE |
| K163005 | TIGR Matrix Surgical Mesh | Novus Scientific AB | Jul 27, 2017 | SESE |
| K143380 | Phasix ST Mesh | C.R. Bard, Inc. | Jun 5, 2015 | SESE |
| K120728 | PHASIX PLUG AND PATCH | C.R. Bard, Inc. | Oct 22, 2012 | SESE |
| K101287 | TEPHAFLEX COMPOSITE MESH | Tepha, Inc. | Aug 30, 2010 | SESE |
| K033671 | GORE BIOABSORBABLE MESH | W. L. Gore & Associates, Inc. | Dec 31, 2003 | SESE |
Top Applicants
- C.R. Bard, Inc. — 4 clearances
- W. L. Gore & Associates, Inc. — 2 clearances
- Novus Scientific AB — 2 clearances
- Tepha, Inc. — 1 clearance
- Sofradim Production — 1 clearance
