GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM— 510(k) K012628

Substantially Equivalent

Gynecare Center

FDA 510(k) clearance K012628 for GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM, Substantially Equivalent on 2001-10-26. Applicant: Gynecare Center.

Clearance details

Applicant: Gynecare Center
Product code: Code OTN
Advisory panel: General, Plastic Surgery
Date received: 2001-08-13
Decision date: 2001-10-26
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.