# K200918: SurgiWrap FROST

- Pathway: 510(k) (Traditional)
- Applicant: Mast Biosurgery
- Decided: Jan 7, 2021 after 276 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
Longest line of descent: 3 generations back to K002699 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050332: Surgi-Wrap Mast Bioresorbable Sheet, Mast Biosurgery USA, Inc. (2005) Summary page 5.

## Indications for use
The SurgiWrap FROST Bioresorbable Protective Sheet is to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists 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. This includes, but is not limited to the following procedures: colon and rectal prolapse. The resorbable Protective Film minimizes tissue attachment to the device in case of direct contact with the viscera. The device is indicated for open and laparoscopic procedures.

Source page: https://510kreport.com/device/K200918
Methodology: https://510kreport.com/methodology