510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
FKDClass II

Canister, Coil

21 CFR 876.5820 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FKD is the FDA product code for Canister, Coil, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
FKD
Device name
Canister, Coil
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code FKD

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

Applicants with the most clearances

Product code FKD
Applicants holding the most 510(k) clearances under product code FKD
ApplicantClearances
Estracorporeal, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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