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

Dilator, Esophageal, Ent

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

KCF is the FDA product code for Dilator, 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
KCF
Device name
Dilator, 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 KCF

By decision year
3 clearances under product code KCF with a decision year between 1981 and 1996, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KCF by decision year
YearClearances
19811
19921
19961

Applicants with the most clearances

Product code KCF
Applicants holding the most 510(k) clearances under product code KCF
ApplicantClearances
Boston Medical Products, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 33 companies shown, in name order