DeviceClearance

Product code GFF— General, Plastic Surgery

SURGICAL BUR

Classification name
Bur, Surgical, General & Plastic Surgery
Device class
Class 1
Regulation
21 CFR 878.4820
Advisory panel
General, Plastic Surgery
Total cleared
16
First cleared
Most recent

Market context for product code GFF

FDA has cleared 16 devices under product code GFF between 1982 and 1998, filed by 13 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code GFF

Adverse events under product code GFF

product code GFF
Malfunction
459
Other
1
Total
460

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 →

Recent clearances under product code GFF

Data sourced from openFDA. This site is unofficial and independent of the FDA.