# K982575: Mesh, Surgical, Polymeric

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Nov 6, 1998 after 105 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 K905655 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922916: Bard Marlex Mesh Dart, C.R. Bard, Inc. (1992) Summary page 1.
- K905655: Nonabsorbable Polypropylene Surgical Mesh, United States Surgical, A Division of Tyco Healthc (1990) Summary page 1.

## Indications for use
The Surgipro* Mesh Plug** device is indicated for the repair of groin hernia defects.

Source page: https://510kreport.com/device/K982575
Methodology: https://510kreport.com/methodology