GOLDFINGER DEVICE— 510(k) K001162

Substantially Equivalent

Mali-Tech , Ltd.

FDA 510(k) clearance K001162 for GOLDFINGER DEVICE, Substantially Equivalent on 2000-08-09. Applicant: Mali-Tech , Ltd..

Clearance details

Applicant: Mali-Tech , Ltd.
Product code: Code FMK
Advisory panel: General, Plastic Surgery
Date received: 2000-04-10
Decision date: 2000-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ginot Shomron 44853, IL

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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.