AMS SACRAL COLPOPEXY SLING, MODEL 72403501— 510(k) K010931

Name: FDA 510(k) clearance K010931
Creator: U.S. Food and Drug Administration
Published: 2001-04-09

Substantially Equivalent

American Medical Systems, Inc.

FDA 510(k) clearance K010931 for AMS SACRAL COLPOPEXY SLING, MODEL 72403501, Substantially Equivalent on 2001-04-09. Applicant: American Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: American Medical Systems, Inc.
Product code: Code OTO
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2001-03-28
Decision date: 2001-04-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OTO

product code OTO

Injury: 840
Total: 840

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.