DERMABRADERS— 510(k) K821485

Name: FDA 510(k) clearance K821485
Creator: U.S. Food and Drug Administration
Published: 1982-06-10

Substantially Equivalent

Spire Medical, Inc.

FDA 510(k) clearance K821485 for DERMABRADERS, Substantially Equivalent on 1982-06-10. Applicant: Spire Medical, Inc.. Device class: 1.

Clearance details

Applicant: Spire Medical, Inc.
Product code: Code GFF
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1982-05-18
Decision date: 1982-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Spire Medical, Inc.

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K821486 — MICRO DRILLS1982-06-09
K802463 — MICRO-SURGICAL POWER INSTRUMENT SYSTEM1980-10-31
K802503 — MICRO-SUGICAL POWER INSTRUMENT SYSTEM1980-10-31

Adverse events under product code GFF

product code GFF

Malfunction: 459
Other: 1
Total: 460

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.