STERNUM SAW BLADE— 510(k) K802838

Substantially Equivalent

Amsco Co.

FDA 510(k) clearance K802838 for STERNUM SAW BLADE, Substantially Equivalent on 1980-12-11. Applicant: Amsco Co..

Clearance details

Applicant: Amsco Co.
Product code: Code GFA
Advisory panel: General, Plastic Surgery
Date received: 1980-11-12
Decision date: 1980-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code GFA

product code GFA

Death: 2
Injury: 140
Malfunction: 2,337
Total: 2,479

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.