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

Clamp, Line

21 CFR 876.4730 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FKK is the FDA product code for Clamp, Line, a class I device type, regulated under 21 CFR 876.4730. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FKK
Device name
Clamp, Line
Regulation
21 CFR 876.4730
Device class
Class I
Review panel
Gastroenterology, Urology
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 FKK

By decision year
6 clearances under product code FKK with a decision year between 1980 and 1985, 1985 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FKK by decision year
YearClearances
19801
19821
19831
19841
19852

Applicants with the most clearances

Product code FKK
Applicants holding the most 510(k) clearances under product code FKK
ApplicantClearances
American Medical Products LLC1
Delmed, Inc.1
Dyn-A-Med Products1
Pollak (Intl.).ltd1
Rao Medical Devices, Inc.1
Travenol Laboratories, S.A.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order