GFG — Bit, Surgical Class I

FDA Device Classification

FDA product code GFG covers "Bit, Surgical", a Class I medical device regulated under 21 CFR 878.4820. Submissions are reviewed by the General, Plastic Surgery panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
GFG
Device Class
Class I
Regulation Number
878.4820
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K935225mitek surgical productsMITEK MODULAR DRILL BITApril 7, 1994
K821486spire medicalMICRO DRILLSJune 9, 1982
K821127key medicalKEY DRILLJune 3, 1982