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

Substantially Equivalent

ETHICON, Inc.

FDA 510(k) clearance K063562 for GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS, Substantially Equivalent on 2007-02-26. Applicant: ETHICON, Inc..

Clearance details

Applicant: ETHICON, Inc.
Product code: Code OTP
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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Adverse events under product code OTP

product code OTP

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.