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

Trocar, Ent

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

KTE is the FDA product code for Trocar, Ent, a class I device type, regulated under 21 CFR 874.4420. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
KTE
Device name
Trocar, 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
1
Ingested recalls
0

Clearances, product code KTE

By decision year
1 clearance under product code KTE with a decision year between 1982 and 1982, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KTE by decision year
YearClearances
19821

Applicants with the most clearances

Product code KTE
Applicants holding the most 510(k) clearances under product code KTE
ApplicantClearances
Kelleher Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 83 companies shown, in name order