# K070846: Minisling Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System

- Pathway: 510(k) (Traditional)
- Applicant: Prosurg, Inc.
- Decided: Jul 2, 2007 after 96 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: 6 generations back to K011251 (2001). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010533: Biosling - Bioabsorbable Polymer Sling & Surgical Mesh, Injectx, Inc. (2001) Summary page 1.
- K030631: Zippere - Bioabsorbable/Non-Absorbable Polymer Sling & Surgical Mesh, Prosurg, Inc. (2003) Summary page 1.
- K063713: Ams Smart Sling System, American Medical Systems, Inc. (2007) Summary page 1.
- K052401: Gynecare TVT Secur System, ETHICON, Inc. (2005) Summary page 1.

## Indications for use
MiniSling TM- Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System is an implant device that is intended for the treatment of Stress Urinary Incontinence (SUI) resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissue where weakness exists in the Urological, Gynecological, Uro-Gynecological or Gastroenterological anatomy. This includes but not limited to the following procedures: Pub urethral support, and Bladder support, Urethral and Vaginal Prolapse Repair, Colon and Rectal Prolapse Repair, Reconstruction of Pelvic floor and Sacral Colposuspension.

Source page: https://510kreport.com/device/K070846
Methodology: https://510kreport.com/methodology