DERMTOME BLADE— 510(k) K962371

Substantially Equivalent

Dsp Worldwide

FDA 510(k) clearance K962371 for DERMTOME BLADE, Substantially Equivalent on 1996-08-29. Applicant: Dsp Worldwide.

Clearance details

Applicant: Dsp Worldwide
Product code: Code GFD
Advisory panel: General, Plastic Surgery
Date received: 1996-06-19
Decision date: 1996-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

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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.