FTM · Mesh, Surgical
General, Plastic Surgery · 21 CFR 878.3300 · Class 2
Overview
| Product Code | FTM |
|---|---|
| Device Name | Mesh, Surgical |
| 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 (20 of 163)
Showing 20 most recent of 163 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250598 | Endoform Reconstructive Template - PLGA | Aroa Biosurgery , Ltd. | Jun 3, 2025 | SESE |
| K243595 | OviTex PRS (Long-Term Resorbable) | TELA Bio, Inc. | Dec 19, 2024 | SESE |
| K233991 | CanGaroo RM Antibacterial Envelope | Elutia, Inc. | Jun 14, 2024 | SESE |
| K241126 | OviTex PRS | TELA Bio, Inc. | May 22, 2024 | SESE |
| K223052 | Peri-Guard and Supple Peri-Guard | Synovis Life Technologies, Inc. | Apr 7, 2023 | SESE |
| K214070 | OviTex PRS (Long Term Resorbable) | Tela Bio | Mar 21, 2023 | SESE |
| K213163 | VersaWrap | Alafair Biosciences, Inc. | Oct 29, 2021 | SESE |
| K213125 | PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology | Synovis Life Technologies. Inc. (A Subsidiary of Baxter | Oct 27, 2021 | SESE |
| K203496 | Nexo-Gide Bilayer Collagen Membrane | Geistlich Pharma AG | Jul 14, 2021 | SESE |
| K203600 | VersaWrap | Alafair Biosciences, Inc. | Mar 9, 2021 | SESE |
| K192452 | Lyograft | B. Bruan Surgical, SA | Sep 3, 2020 | SESE |
| K201000 | Biodesign Staple Line Reinforcement | Cook Biotech Incorporated | Jul 13, 2020 | SESE |
| K201313 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) | Aziyo Biologics, Inc. | Jun 15, 2020 | SESE |
| K200311 | VersaWrap Tendon Protector | Alafair Biosciences, Inc. | Mar 6, 2020 | SESE |
| K192615 | Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) | Synovis Life Technologies, Inc. (Baxter International Inc.) | Dec 17, 2019 | SESE |
| K192616 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ) | Aziyo Biologics, Inc. | Oct 21, 2019 | SESE |
| K182493 | Bovine Pericardial Tissue Patch | Tisgenx | Jun 18, 2019 | SESE |
| K183398 | Endoform Restella | Aroa Biosurgery , Ltd. | Apr 11, 2019 | SESE |
| K183472 | DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio MR Conditional | Synthes (USA) Products, LLC | Mar 13, 2019 | SESE |
| K182259 | Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal | Acell, Inc. | Feb 7, 2019 | SESE |
Top Applicants
- Cook Biotech, Inc. — 14 clearances
- Bio-Vascular, Inc. — 7 clearances
- Tei Biosciences, Inc. — 7 clearances
- Acell, Inc. — 6 clearances
- Cook Biotech Incorporated — 6 clearances
