DeviceClearance

Product code GFA— General, Plastic Surgery

SURGICAL SAW BLADES

Classification name
Blade, Saw, General & Plastic Surgery, Surgical
Device class
Class 1
Regulation
21 CFR 878.4820
Advisory panel
General, Plastic Surgery
Total cleared
27
First cleared
Most recent

Market context for product code GFA

FDA has cleared 27 devices under product code GFA between 1980 and 1997, filed by 21 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 GFA

Adverse events under product code GFA

product code GFA
Death
2
Injury
140
Malfunction
2,337
Total
2,479

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 GFA

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