MICRO-AIRE REPLACEMENT DRILL BURS— 510(k) K820281

Name: FDA 510(k) clearance K820281
Creator: U.S. Food and Drug Administration
Published: 1982-02-23

Substantially Equivalent

Micro-Aire Surgical Instruments, Inc.

FDA 510(k) clearance K820281 for MICRO-AIRE REPLACEMENT DRILL BURS, Substantially Equivalent on 1982-02-23. Applicant: Micro-Aire Surgical Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Micro-Aire Surgical Instruments, Inc.
Product code: Code GFF
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1982-02-02
Decision date: 1982-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K894438 — MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS1989-08-21

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K903650 — OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-3051990-09-14
K903713 — OSTEOTOME MODEL NUMBERS 2500-228 & 2500-2291990-09-14
K903664 — MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL1990-09-13

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.