QA-ES— 510(k) K971092

Substantially Equivalent

Smith

FDA 510(k) clearance K971092 for QA-ES, Substantially Equivalent on 1997-04-23. Applicant: Smith.

Clearance details

Applicant: Smith
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 1997-03-26
Decision date: 1997-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, US

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.