MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR— 510(k) K862852

Substantially Equivalent

Micro-Aire Surgical Instruments, Inc.

FDA 510(k) clearance K862852 for MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR, Substantially Equivalent on 1986-08-11. Applicant: Micro-Aire Surgical Instruments, Inc..

Clearance details

Applicant: Micro-Aire Surgical Instruments, Inc.
Product code: Code GFF
Advisory panel: General, Plastic Surgery
Date received: 1986-07-29
Decision date: 1986-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Fernando, CA, US

Download summary PDF View on FDA.gov ↗

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.