AMS COAGULOOP RESECTION ELECTRODE— 510(k) K971512

Substantially Equivalent

American Medical Systems, Inc.

FDA 510(k) clearance K971512 for AMS COAGULOOP RESECTION ELECTRODE, Substantially Equivalent on 1997-07-24. Applicant: American Medical Systems, Inc..

Clearance details

Applicant: American Medical Systems, Inc.
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 1997-04-28
Decision date: 1997-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

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Adverse events under product code FAS

product code FAS

Death: 3
Injury: 344
Malfunction: 1,130
Total: 1,477

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.