OOD · Surgical Film
General, Plastic Surgery · 21 CFR 878.3300 · Class 2
Overview
| Product Code | OOD |
|---|---|
| Device Name | Surgical Film |
| Regulation | 21 CFR 878.3300 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
| Life-Sustaining | 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 (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233999 | GalaFLEX LITE Scaffold | Tepha, Inc. | Apr 9, 2024 | SESE |
| K202425 | SurgiLattice scaffold | Tepha, Inc. | Aug 19, 2021 | SESE |
| K162922 | GalaFORM 3D | Tepha, Inc. | Feb 23, 2017 | SESE |
| K161424 | Phasix Mesh | C.R. Bard, Inc. | Sep 29, 2016 | SESE |
| K161092 | GalaSHAPE 3D | Tepha, Inc. | Aug 23, 2016 | SESE |
| K142818 | Phasix Mesh | C. R. Bard | Mar 31, 2015 | SESE |
| K140533 | GALAFLEX MESH | Tepha, Inc. | May 21, 2014 | SESE |
| K130326 | TEPHAFLEX MELTBLOWN CONSTRUCT | Tepha, Inc. | May 7, 2013 | SESE |
| K113723 | TEPHAFLEX MESH | Tepha, Inc. | Feb 15, 2012 | SESE |
| K113721 | TEPHAFLEX LIGHT MESH | Tepha, Inc. | Feb 15, 2012 | SESE |
| K111946 | TEPHAFLEX MESH | Tepha, Inc. | Sep 26, 2011 | SESE |
| K091633 | TEPHAFLEX SURGICAL FILM | Tepha, Inc. | Aug 7, 2009 | SESE |
| K070894 | TEPHAFLEX SURGICAL MESH | Tepha, Inc. | Apr 13, 2007 | SESE |
Top Applicants
- Tepha, Inc. — 11 clearances
- C.R. Bard, Inc. — 1 clearance
- C. R. Bard — 1 clearance
