Surgical Film
General, Plastic Surgery · 21 CFR 878.3300
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.
Recent MDR events
1,213 adverse event reports on file
- Phasix MeshJul 31, 2026InjuryDavol Inc., Sub. C.r. Bard, Inc. -12136431213643-2026-00993
- Phasix MeshJul 31, 2026InjuryDavol Inc., Sub. C.r. Bard, Inc. -12136431213643-2026-00995
- Phasix MeshJul 31, 2026InjuryDavol Inc., Sub. C.r. Bard, Inc. -12136431213643-2026-00996
- GalaFlex LiteJul 30, 2026InjuryTepha, Inc. - 30056707601213643-2026-00985
- Phasix MeshJul 28, 2026InjuryDavol Inc., Sub. C.r. Bard, Inc. -12136431213643-2026-00949
- GalaFlex LiteJul 28, 2026InjuryTepha, Inc. - 30056707601213643-2026-00961
- GalaFlex LiteJul 28, 2026InjuryTepha, Inc. - 30056707601213643-2026-00962
- GalaFlex LiteJul 28, 2026InjuryTepha, Inc. - 30056707601213643-2026-00963
- GalaFlex LiteJul 28, 2026InjuryTepha, Inc. - 30056707601213643-2026-00964
- Phasix MeshJul 28, 2026InjuryDavol Inc., Sub. C.r. Bard, Inc. -12136431213643-2026-00966
Event type breakdown
Registered firms
40 firms currently registered for this product code
Synergy Health Ede Bv
Venlo Limburg, NL
Xiamen Mk Health Care Product Co., Ltd.
XIAMEN Fujian, CN
Davol Inc., Sub. C.r. Bard, Inc.
Warwick, RI, US
C.r. Bard, Inc.
MADISON, GA, US
Tepha, Incorporated
Lexington, MA, US
Sterlab
SIGNES Var, FR
Bard Shannon Limited
Humacao, PR, US
Sofradim Production
TREVOUX Auvergne-Rhone-Alpes, FR
510(k) clearances
13 clearances for this product code
- Tepha, Inc.Apr 9, 2024
K233999 · GalaFLEX LITE Scaffold
- Tepha, Inc.Aug 19, 2021
K202425 · SurgiLattice scaffold
- Tepha, Inc.Feb 23, 2017
K162922 · GalaFORM 3D
- C.R. Bard, Inc.Sep 29, 2016
K161424 · Phasix Mesh
- Tepha, Inc.Aug 23, 2016
K161092 · GalaSHAPE 3D
- C. R. BardMar 31, 2015
K142818 · Phasix Mesh
- Tepha, Inc.May 21, 2014
K140533 · GALAFLEX MESH
- Tepha, Inc.May 7, 2013
K130326 · TEPHAFLEX MELTBLOWN CONSTRUCT