SURESHARP— 510(k) K950159

Substantially Equivalent

Gainor Medical U.S.A., Inc.

FDA 510(k) clearance K950159 for SURESHARP, Substantially Equivalent on 1995-04-14. Applicant: Gainor Medical U.S.A., Inc..

Clearance details

Applicant: Gainor Medical U.S.A., Inc.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 1995-01-17
Decision date: 1995-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcdonough, GA, US

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Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.