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

Mold, Middle-Ear

21 CFR 874.3430 / Ear, Nose, Throat
FDA source (opens on fda.gov)

ETC is the FDA product code for Mold, Middle-Ear, a class II device type, regulated under 21 CFR 874.3430. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
ETC
Device name
Mold, Middle-Ear
Regulation
21 CFR 874.3430
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k) exempt
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code ETC

By decision year
1 clearance under product code ETC with a decision year between 1993 and 1993, 1993 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ETC by decision year
YearClearances
19931

Applicants with the most clearances

Product code ETC
Applicants holding the most 510(k) clearances under product code ETC
ApplicantClearances
Smith & Nephew Richards, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code