AMS SOFT-TISSUE APPROXIMATION SYSTEM— 510(k) K012342

Substantially Equivalent

American Medical Systems, Inc.

FDA 510(k) clearance K012342 for AMS SOFT-TISSUE APPROXIMATION SYSTEM, Substantially Equivalent on 2001-09-05. Applicant: American Medical Systems, Inc..

Clearance details

Applicant: American Medical Systems, Inc.
Product code: Code FZP
Advisory panel: General, Plastic Surgery
Date received: 2001-07-24
Decision date: 2001-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

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Adverse events under product code FZP

product code FZP

Death: 11
Injury: 726
Malfunction: 10,830
Other: 1
Total: 11,568

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.