510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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GFGClass I

Bit, Surgical

21 CFR 878.4820 / General, Plastic Surgery
FDA source (opens on fda.gov)

GFG is the FDA product code for Bit, Surgical, a class I device type, regulated under 21 CFR 878.4820. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 17 recalls.

Classification record

Product code
GFG
Device name
Bit, Surgical
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
3
Ingested recalls
17

Clearances, product code GFG

By decision year
3 clearances under product code GFG with a decision year between 1982 and 1994, 1982 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GFG by decision year
YearClearances
19822
19941

Applicants with the most clearances

Product code GFG
Applicants holding the most 510(k) clearances under product code GFG
ApplicantClearances
Key Medical, Inc.1
Mitek Surgical Products, Inc.1
Spire Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 87 companies shown, in name order