GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS— 510(k) K063562

Clearance details

Applicant

ETHICON, Inc.

Product code

Code OTP

Device class

Class 3

Regulation

21 CFR 884.5980

Advisory panel

Obstetrics/Gynecology

Date received

2006-11-27

Decision date

2007-02-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Somerville, NJ, US

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Injury

1,061

Total

1,061

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →