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

Saw, Pneumatically Powered

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

KFK is the FDA product code for Saw, Pneumatically Powered, a class I device type, regulated under 21 CFR 878.4820. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
KFK
Device name
Saw, Pneumatically Powered
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
4
Ingested recalls
1

Clearances, product code KFK

By decision year
4 clearances under product code KFK with a decision year between 1980 and 1989, 1989 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KFK by decision year
YearClearances
19801
19871
19892

Applicants with the most clearances

Product code KFK
Applicants holding the most 510(k) clearances under product code KFK
ApplicantClearances
Amsco Co.1
Medmark, Inc.1
Micro Surgical Instruments Corp.1
Micro-Aire Surgical Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order