BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996— 510(k) K040538

Substantially Equivalent

American Medical Systems, Inc.

FDA 510(k) clearance K040538 for BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996, Substantially Equivalent on 2004-03-17. Applicant: American Medical Systems, Inc..

Clearance details

Applicant: American Medical Systems, Inc.
Product code: Code OTN
Advisory panel: General, Plastic Surgery
Date received: 2004-03-02
Decision date: 2004-03-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

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.