PADGETT AIR DERMATOME, MODEL A— 510(k) K951085

Name: FDA 510(k) clearance K951085
Creator: U.S. Food and Drug Administration
Published: 1995-05-15

Substantially Equivalent

Padgett Instruments, Inc.

FDA 510(k) clearance K951085 for PADGETT AIR DERMATOME, MODEL A, Substantially Equivalent on 1995-05-15. Applicant: Padgett Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Padgett Instruments, Inc.
Product code: Code GFD
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1995-03-09
Decision date: 1995-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MO, US

Download summary PDF View on FDA.gov ↗

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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.