OOD
13 FDA 510(k) clearances · Product code
88 daysmedian time to decision
183 days90th percentile
13clearances measured
FDA profile
- Official device name
- Surgical Film
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant · Life-sustaining
- FDA definition
- To be implanted to reinforce soft tissue or bone where weakness exists. Intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological, or gastrointestinal anatomy, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The absorbable protective film also may help minimize the potential for tissue attachment to the device in case of direct contact with the viscera.
- Adverse events (MAUDE)
- 2021: 98 · 2022: 430 · 2023: 125 · 2024: 196 · 2025: 111 · 2026: 92
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| GalaFLEX LITE Scaffold (K233999) | Tepha, Inc. | 2024-04-09 |
| SurgiLattice scaffold (K202425) | Tepha, Inc. | 2021-08-19 |
| GalaFORM 3D (K162922) | Tepha, Inc. | 2017-02-23 |
| Phasix Mesh (K161424) | C.R. Bard, Inc. | 2016-09-29 |
| GalaSHAPE 3D (K161092) | Tepha, Inc. | 2016-08-23 |
| Phasix Mesh (K142818) | C. R. Bard | 2015-03-31 |
| GALAFLEX MESH (K140533) | Tepha, Inc. | 2014-05-21 |
| TEPHAFLEX MELTBLOWN CONSTRUCT (K130326) | Tepha, Inc. | 2013-05-07 |
| TEPHAFLEX LIGHT MESH (K113721) | Tepha, Inc. | 2012-02-15 |
| TEPHAFLEX MESH (K113723) | Tepha, Inc. | 2012-02-15 |
| TEPHAFLEX MESH (K111946) | Tepha, Inc. | 2011-09-26 |
| TEPHAFLEX SURGICAL FILM (K091633) | Tepha, Inc. | 2009-08-07 |
| TEPHAFLEX SURGICAL MESH (K070894) | Tepha, Inc. | 2007-04-13 |
Track OOD automatically
Every clearance here is in the API, with alerts when new ones post.