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

Name: FDA 510(k) clearance K040538
Creator: U.S. Food and Drug Administration
Published: 2004-03-17

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.. Device class: 2.

Clearance details

Applicant: American Medical Systems, Inc.
Product code: Product code OTN
Device class: Class 2
Regulation: 21 CFR 878.3300
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

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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.