BLADES, WHISKERS, TRIMMERS, CUTTERS, AND BURS— 510(k) K912108

Substantially Equivalent

Microaire Advanced Surgical Products

FDA 510(k) clearance K912108 for BLADES, WHISKERS, TRIMMERS, CUTTERS, AND BURS, Substantially Equivalent on 1991-07-02. Applicant: Microaire Advanced Surgical Products.

Clearance details

Applicant
Microaire Advanced Surgical Products
Product code
Code HRX
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Valencia, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HRX

product code HRX
Injury
623
Malfunction
11,257
Total
11,880

Source: openFDA MAUDE database, through . 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.