OOD — Surgical Film Class II

FDA Device Classification

Classification Details

Product Code
OOD
Device Class
Class II
Regulation Number
878.3300
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
Yes

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233999tephaGalaFLEX LITE ScaffoldApril 9, 2024
K202425tephaSurgiLattice scaffoldAugust 19, 2021
K162922tephaGalaFORM 3DFebruary 23, 2017
K161424c.r. bardPhasix MeshSeptember 29, 2016
K161092tephaGalaSHAPE 3DAugust 23, 2016
K142818c. r. bardPhasix MeshMarch 31, 2015
K140533tephaGALAFLEX MESHMay 21, 2014
K130326tephaTEPHAFLEX MELTBLOWN CONSTRUCTMay 7, 2013
K113721tephaTEPHAFLEX LIGHT MESHFebruary 15, 2012
K113723tephaTEPHAFLEX MESHFebruary 15, 2012
K111946tephaTEPHAFLEX MESHSeptember 26, 2011
K091633tephaTEPHAFLEX SURGICAL FILMAugust 7, 2009
K070894tephaTEPHAFLEX SURGICAL MESHApril 13, 2007