GFFClass I

Bur, Surgical, General & Plastic Surgery

21 CFR 878.4820 / General, Plastic Surgery

GFF is the FDA product code for Bur, Surgical, General & Plastic Surgery, a class I device type, regulated under 21 CFR 878.4820. As of 2026-09-10, FDA records hold 16 510(k) clearances under this code, the most recent dated 1998-07-06, and 13 recalls.

Classification record

Product code: GFF
Device name: Bur, Surgical, General & Plastic Surgery
Regulation: 21 CFR 878.4820
Device class: Class I
Review panel: General, Plastic Surgery
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 16
Ingested recalls: 13

Clearances, product code GFF

By decision year

16 clearances under product code GFF with a decision year between 1982 and 1998, 1988 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code GFF by decision year
Year	Clearances
1982	2
1984	1
1985	2
1986	1
1987	1
1988	3
1989	2
1994	2
1995	1
1998	1

Applicants with the most clearances

Product code GFF

Applicants holding the most 510(k) clearances under product code GFF
Applicant	Clearances
Micro-Aire Surgical Instruments, Inc.	4
Acumed Instruments Corp.	1
American Medical Specialties, Inc.	1
Danek Medical, Inc.	1
Komet Medical	1
Komet Medical, Div. of Brasseler USA I, L.P.	1
New England Surgical Instrument Corp.	1
Nuell Air Equipment & Hospital Supplies, Inc.	1
Spire Medical, Inc.	1
Tava Surgical Instruments	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 159 companies shown, in name order