SURELITE AND SURELITE XL BLOOD LANCET— 510(k) K902416

Substantially Equivalent

Gainor Medical Europe, Ltd.

FDA 510(k) clearance K902416 for SURELITE AND SURELITE XL BLOOD LANCET, Substantially Equivalent on 1990-08-01. Applicant: Gainor Medical Europe, Ltd..

Clearance details

Applicant: Gainor Medical Europe, Ltd.
Product code: Code FMK
Advisory panel: General, Plastic Surgery
Date received: 1990-05-31
Decision date: 1990-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcdonough, GA, US

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Adverse events under product code FMK

product code FMK

Injury: 133
Malfunction: 1,278
Other: 1
Total: 1,412

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.