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

Blade, Saw, General & Plastic Surgery, Surgical

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

GFA is the FDA product code for Blade, Saw, General & Plastic Surgery, Surgical, a class I device type, regulated under 21 CFR 878.4820. As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and 19 recalls.

Classification record

Product code
GFA
Device name
Blade, Saw, General & Plastic Surgery, 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
27
Ingested recalls
19

Clearances, product code GFA

By decision year
27 clearances under product code GFA with a decision year between 1980 and 1997, 1994 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code GFA by decision year
YearClearances
19801
19812
19822
19832
19852
19862
19891
19911
19933
19946
19952
19962
19971

Applicants with the most clearances

Product code GFA
Applicants holding the most 510(k) clearances under product code GFA
ApplicantClearances
Micro-Aire Surgical Instruments, Inc.4
Boehringer Laboratories, LLC2
Omega Surgical Instruments, Inc.2
Wrightmedicaltechnologyinc2
3M Health Care, Sarns1
Adven Medical1
American Medical Specialties, Inc.1
Amsco Co.1
Anadias, Inc.1
Blairden Precision Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 271 companies shown, in name order