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

Tube, Laryngectomy

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

KAC is the FDA product code for Tube, Laryngectomy, a class I device type, regulated under 21 CFR 874.4420. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
KAC
Device name
Tube, Laryngectomy
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
4
Ingested recalls
1

Clearances, product code KAC

By decision year
4 clearances under product code KAC with a decision year between 1981 and 1990, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KAC by decision year
YearClearances
19811
19821
19881
19901

Applicants with the most clearances

Product code KAC
Applicants holding the most 510(k) clearances under product code KAC
ApplicantClearances
Medical Innovations International1
Abbott Medical1
Shiley, Inc.1
Universal Prosthetics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 32 companies shown, in name order