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

Applicator, Ent

21 CFR 874.5220 / Ear, Nose, Throat
FDA source (opens on fda.gov)

KCJ is the FDA product code for Applicator, Ent, a class I device type, regulated under 21 CFR 874.5220. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
KCJ
Device name
Applicator, Ent
Regulation
21 CFR 874.5220
Device class
Class I
Review panel
Ear, Nose, Throat
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
4
Ingested recalls
1

Clearances, product code KCJ

By decision year
4 clearances under product code KCJ with a decision year between 1983 and 1992, 1992 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KCJ by decision year
YearClearances
19831
19891
19922

Applicants with the most clearances

Product code KCJ
Applicants holding the most 510(k) clearances under product code KCJ
ApplicantClearances
Apdyne Medical Co.1
Ethicon Endo-Surgery Inc1
Kells Medical, Inc.1
Laparomed Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 124 companies shown, in name order