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

Device, Anti-Stammering

21 CFR 874.5840 / Ear, Nose, Throat
FDA source (opens on fda.gov)

KTH is the FDA product code for Device, Anti-Stammering, a class I device type, regulated under 21 CFR 874.5840. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KTH
Device name
Device, Anti-Stammering
Regulation
21 CFR 874.5840
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
0

Clearances, product code KTH

By decision year
4 clearances under product code KTH with a decision year between 1980 and 1996, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KTH by decision year
YearClearances
19801
19871
19951
19961

Applicants with the most clearances

Product code KTH
Applicants holding the most 510(k) clearances under product code KTH
ApplicantClearances
Casa Futura Technologies1
Foundation for Fluency, Inc.1
Surface Mount Technology, Inc.1
Vocaltech C/O Hogan & Hartson1

Companies listing this code with FDA

Companies whose registered establishments list this code