# K915526: Coated Surgipro (TM) Polypropylene Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: May 29, 1992 after 171 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K073164: Ivs Tunneller Devices (2008), 0 descendants of its own

## Recalls of this device
- Dec 15, 2010 · Not classified · Z-1009-2011: Sterility compromised due to breach in sterile barrier

Source page: https://510kreport.com/device/K915526
Methodology: https://510kreport.com/methodology
