# K102815: Surelift Prolapse System

- Pathway: 510(k) (Traditional)
- Applicant: Neomedic International
- Decided: Jul 7, 2011 after 282 days
- Product code: OTP (Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed)
- Device class: 3
- Regulation: 21 CFR 884.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K931386 (1993). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080185: Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen LP Prolapse Repair System, American Medical Systems, Inc. (2008)
- K071512: Gynecare Prolift +M* Pelvic Floor Repair Systems, ETHICON, Inc. (2008)

## Indications for use
The SURELIFT PROLAPSE SYSTEM is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and posterior vaginal wall prolapse. The kit includes instrumentation for transvaginal placement.

Source page: https://510kreport.com/device/K102815
Methodology: https://510kreport.com/methodology