# K030631: Zippere - Bioabsorbable/Non-Absorbable Polymer Sling & Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Prosurg, Inc.
- Decided: May 19, 2003 after 80 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.
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’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K070846: Minisling Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System (2007), 0 descendants of its own

## Indications for use
Zipperem - Bioabsorbable / Non-absorbable Polymer Sling and Surgical Mesh is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissue where weakness exists in the urological, gynecological or gastroentrological anatomy. This includes, but not limited to, the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and secral colpuspension.

Source page: https://510kreport.com/device/K030631
Methodology: https://510kreport.com/methodology