Surgical Film

FDA product code OOD · Class II (moderate risk) · 21 CFR 878.3300 · General, Plastic Surgery

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.

13510(k) clearances
0PMA approvals
1recalls
Implantimplanted device

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K233999GalaFLEX LITE ScaffoldOOD · Traditional Tepha, Inc.04/09/2024SE
K202425SurgiLattice scaffoldOOD · Traditional Tepha, Inc.08/19/2021SE
K162922GalaFORM 3DOOD · Traditional Tepha, Inc.02/23/2017SE
K161424Phasix MeshOOD · Traditional C.R. Bard, Inc.09/29/2016SE
K161092GalaSHAPE 3DOOD · Traditional Tepha, Inc.08/23/2016SE
K142818Phasix MeshOOD · Traditional C. R. Bard03/31/2015SE
K140533Galaflex MeshOOD · Traditional Tepha, Inc.05/21/2014SE
K130326Tephaflex Meltblown ConstructOOD · Traditional Tepha, Inc.05/07/2013SE
K113723Tephaflex MeshOOD · Traditional Tepha, Inc.02/15/2012SE
K113721Tephaflex Light MeshOOD · Traditional Tepha, Inc.02/15/2012SE
K111946Tephaflex MeshOOD · Traditional Tepha, Inc.09/26/2011SE
K091633Tephaflex Surgical FilmOOD · Traditional Tepha, Inc.08/07/2009SE
K070894Tephaflex Surgical MeshOOD · Traditional Tepha, Inc.04/13/2007SE

Recalls

RecallProductFirmInitiated
Z-0948-2017 Class IIGalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use…Endotoxin values from testing of retains slightly exceeded the established specification. Tepha Incorporated11/21/2016Terminated