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

Tube, Toynbee Diagnostic

21 CFR 874.1925 / Ear, Nose, Throat
FDA source (opens on fda.gov)

ETK is the FDA product code for Tube, Toynbee Diagnostic, a class I device type, regulated under 21 CFR 874.1925. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
ETK
Device name
Tube, Toynbee Diagnostic
Regulation
21 CFR 874.1925
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 ETK

By decision year
1 clearance under product code ETK with a decision year between 1983 and 1983, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ETK by decision year
YearClearances
19831

Applicants with the most clearances

Product code ETK
Applicants holding the most 510(k) clearances under product code ETK
ApplicantClearances
Antares Technical Associates, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code