GYNECARE TVT ABBREVO CONTINENCE SYSTEM— 510(k) K100936

Substantially Equivalent

ETHICON, Inc.

FDA 510(k) clearance K100936 for GYNECARE TVT ABBREVO CONTINENCE SYSTEM, Substantially Equivalent on 2010-07-01. Applicant: ETHICON, Inc..

Clearance details

Applicant: ETHICON, Inc.
Product code: Code OTN
Advisory panel: General, Plastic Surgery
Date received: 2010-04-05
Decision date: 2010-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
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.