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

Tip, Vessel

21 CFR 876.5540 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FKW is the FDA product code for Tip, Vessel, a class II device type, regulated under 21 CFR 876.5540. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FKW
Device name
Tip, Vessel
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code FKW

By decision year
3 clearances under product code FKW with a decision year between 1979 and 1989, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FKW by decision year
YearClearances
19791
19811
19891

Applicants with the most clearances

Product code FKW
Applicants holding the most 510(k) clearances under product code FKW
ApplicantClearances
Akcess Medical Products, Inc.1
Quinton, Inc.1
Vickers America Medical Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code FKW.