DECA DERMATOME (MICROMOTOR SYSTEM)— 510(k) K945594

Substantially Equivalent

Depuy Intl., Ltd.

FDA 510(k) clearance K945594 for DECA DERMATOME (MICROMOTOR SYSTEM), Substantially Equivalent on 1995-06-05. Applicant: Depuy Intl., Ltd..

Clearance details

Applicant: Depuy Intl., Ltd.
Product code: Code GFD
Advisory panel: General, Plastic Surgery
Date received: 1994-11-14
Decision date: 1995-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Yorkshire, GB

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Adverse events under product code GFD

product code GFD

Injury: 544
Malfunction: 3,575
Other: 1
Total: 4,120

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.