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

Osteotome, Manual

21 CFR 878.4800 / General, Plastic Surgery
FDA source (opens on fda.gov)

GFI is the FDA product code for Osteotome, Manual, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GFI
Device name
Osteotome, Manual
Regulation
21 CFR 878.4800
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
6
Ingested recalls
0

Clearances, product code GFI

By decision year
6 clearances under product code GFI with a decision year between 1984 and 1993, 1993 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GFI by decision year
YearClearances
19841
19851
19891
19921
19932

Applicants with the most clearances

Product code GFI
Applicants holding the most 510(k) clearances under product code GFI
ApplicantClearances
Biomerieux Vitek, Inc.1
Cher Mel Corp.1
Innovative Surgical, Inc.1
Storz Instrument Co.1
Medtronic, Inc.1
Zinnanti Surgical Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 137 companies shown, in name order