K010990

Substantially Equivalent

AMS SLING FIXATION SYSTEM

Applicant: American Medical Systems, Inc.
Product code: GAW
Advisory panel: General, Plastic Surgery
Date received: 2001-04-03
Decision date: 2001-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Adverse events under product code GAW

product code GAW

Death: 66
Injury: 1,616
Malfunction: 10,428
Total: 12,110

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.