DERMAPUNCH DISPOSABLE SKIN BIOPSY PUNCH— 510(k) K925653

Name: FDA 510(k) clearance K925653
Creator: U.S. Food and Drug Administration
Published: 1993-11-08

Substantially Equivalent

Dermatopathology Laboratory

FDA 510(k) clearance K925653 for DERMAPUNCH DISPOSABLE SKIN BIOPSY PUNCH, Substantially Equivalent on 1993-11-08. Applicant: Dermatopathology Laboratory. Device class: 1.

Clearance details

Applicant: Dermatopathology Laboratory
Product code: Code MDM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1992-11-09
Decision date: 1993-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New South Wales,Australia, AU

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MDM

product code MDM

Injury: 247
Malfunction: 1,516
Total: 1,763

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.