# K072520: Tephaflex Surgical Film

- Pathway: 510(k) (Traditional)
- Applicant: Tepha, Inc.
- Decided: Nov 29, 2007 after 83 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Surgi-Wrap Film: named in the summary without a submission number
- (no number) PlastiFilm: named in the summary without a submission number
- (no number) TephaFLEX Absorbable Mesh: named in the summary without a submission number

## Indications for use
TephaFLEX® Surgical Film is intended for temporary wound support, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing 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.

Source page: https://510kreport.com/device/K072520
Methodology: https://510kreport.com/methodology