MONARC SLING SYSTEM— 510(k) K023516

Substantially Equivalent

American Medical Systems, Inc.

FDA 510(k) clearance K023516 for MONARC SLING SYSTEM, Substantially Equivalent on 2002-11-19. Applicant: American Medical Systems, Inc..

Clearance details

Applicant: American Medical Systems, Inc.
Product code: Code OTN
Advisory panel: General, Plastic Surgery
Date received: 2002-10-21
Decision date: 2002-11-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Minnetonka, MN, 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.