Product Code: GFC FDA class 1 21 CFR 878.4820

Driver, Surgical, Pin

General, Plastic Surgery

The Driver, Surgical, Pin (product code GFC) is a powered or manual instrument attachment used to drive pins or fixation hardware during general and plastic surgery procedures. It is classified as an FDA Class 1 device, representing the lowest risk tier, subject to general controls and not requiring premarket notification. Regulated under 21 CFR 878.4820 in the General, Plastic Surgery specialty (SU), this device has no special flags for implantation, life support, GMP exemption, or third-party review.

510(k)s
2
FEI Numbers
86
Registration Numbers
86
Unique Applicants
2
Years Active
0

Research product code GFC in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Basic Information

Product Code
GFC
Device Class
FDA class 1
Regulation Number
878.4820
Medical Specialty
General, Plastic Surgery
Review Panel
SU
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

Loading...

Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K781450 DRIVERS
K780255 NEEDLE DRIVER

FEI Numbers

This FDA classification entry is associated with 86 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 86 registration numbers. Click on an entry to view related FDA registrations.