Product code GFG— General, Plastic Surgery

KEY DRILL

Classification name: Bit, Surgical
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Total cleared: 3
First cleared: 1982-06-03
Most recent: 1994-04-07

Market context for product code GFG

FDA has cleared 3 devices under product code GFG between 1982 and 1994, filed by 3 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

19941 clearance
19822 clearances

Top applicants under product code GFG

Spire Medical, Inc.1 clearance
Mitek Surgical Products, Inc.1 clearance
Key Medical, Inc.1 clearance

Recent clearances under product code GFG

K935225 — MITEK MODULAR DRILL BITMitek Surgical Products, Inc.·1994-04-07
K821486 — MICRO DRILLSSpire Medical, Inc.·1982-06-09
K821127 — KEY DRILLKey Medical, Inc.·1982-06-03

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