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
KCDClass I

Bougie, Esophageal, Ent

21 CFR 874.4420 / Ear, Nose, Throat
FDA source (opens on fda.gov)

KCD is the FDA product code for Bougie, Esophageal, Ent, a class I device type, regulated under 21 CFR 874.4420. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KCD
Device name
Bougie, Esophageal, Ent
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code KCD

By decision year
3 clearances under product code KCD with a decision year between 1980 and 1984, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KCD by decision year
YearClearances
19801
19821
19841

Applicants with the most clearances

Product code KCD
Applicants holding the most 510(k) clearances under product code KCD
ApplicantClearances
Glaxo, Inc.1
Kelleher Corp.1
Pilling Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order