RETROARC RETROPUBIC SLING SYSTEM— 510(k) K132655

Substantially Equivalent

American Medical Systems, Inc.

FDA 510(k) clearance K132655 for RETROARC RETROPUBIC SLING SYSTEM, Substantially Equivalent on 2013-11-20. Applicant: American Medical Systems, Inc..

Clearance details

Applicant: American Medical Systems, Inc.
Product code: Code OTN
Advisory panel: General, Plastic Surgery
Date received: 2013-08-26
Decision date: 2013-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
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.