# K070018: Universal Surgical Mesh, Model 100

- Pathway: 510(k) (Traditional)
- Applicant: Generic Medical Device, Inc.
- Decided: Apr 27, 2007 after 114 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: 1 generation back to K962530 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962530: Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh, ETHICON, Inc. (1996) Summary page 1.

## Indications for use
The Universal Surgical Mesh is indicated 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.

Source page: https://510kreport.com/device/K070018
Methodology: https://510kreport.com/methodology