GYNECARE TVT EXACT CONTINENCE SYSTEM— 510(k) K132054

Substantially Equivalent

ETHICON, Inc.

FDA 510(k) clearance K132054 for GYNECARE TVT EXACT CONTINENCE SYSTEM, Substantially Equivalent on 2013-08-23. Applicant: ETHICON, Inc..

Clearance details

Applicant: ETHICON, Inc.
Product code: Code OTN
Advisory panel: General, Plastic Surgery
Date received: 2013-07-03
Decision date: 2013-08-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Somerville, NJ, US

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Adverse events under product code OTN

product code OTN

Injury: 6,630
Total: 6,630

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.