# K063562: Gynecare Prosima Pelvic Floor Repair Systems

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Feb 26, 2007 after 91 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GYNECARE GYNEMESH* PS Nonabsorbable PROLENE* Soft Mesh: named in the summary without a submission number
- (no number) Silimed Vaginal Stent: named in the summary without a submission number

## Indications for use
The GYNECARE PROSIMA* Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH* PS Nonabsorbable PROLENE Soft Mesh, are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor, either as mechanical support or bridging material for the fascial defect. The Systems provide maintenance of the vaginal canal during the period of healing following surgical repair of vaginal wall prolapse, while supporting the position of the Mesh Implants.

Source page: https://510kreport.com/device/K063562
Methodology: https://510kreport.com/methodology