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

Ear Wick

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

KCN is the FDA product code for Ear Wick, 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 6 recalls.

Classification record

Product code
KCN
Device name
Ear Wick
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
6

Clearances, product code KCN

By decision year
4 clearances under product code KCN with a decision year between 1979 and 2006, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KCN by decision year
YearClearances
19791
19931
19971
20061

Applicants with the most clearances

Product code KCN
Applicants holding the most 510(k) clearances under product code KCN
ApplicantClearances
Invotec International, Inc.1
Polyganics B.V.1
Ultracell Medical Technologies, Inc.1
Xomed, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 24 companies shown, in name order