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

Driver, Surgical, Pin

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

GFC is the FDA product code for Driver, Surgical, Pin, a class I device type, regulated under 21 CFR 878.4820. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
GFC
Device name
Driver, Surgical, Pin
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
2
Ingested recalls
2

Clearances, product code GFC

By decision year
2 clearances under product code GFC with a decision year between 1978 and 1978, 1978 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GFC by decision year
YearClearances
19782

Applicants with the most clearances

Product code GFC
Applicants holding the most 510(k) clearances under product code GFC
ApplicantClearances
Orthopedic Equipment Co., Inc.1
Scanlan Intl., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 85 companies shown, in name order