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

Bur, Ear, Nose And Throat

21 CFR 874.4140 / Ear, Nose, Throat
FDA source (opens on fda.gov)

EQJ is the FDA product code for Bur, Ear, Nose And Throat, a class I device type, regulated under 21 CFR 874.4140. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
EQJ
Device name
Bur, Ear, Nose And Throat
Regulation
21 CFR 874.4140
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
18
Ingested recalls
4

Clearances, product code EQJ

By decision year
18 clearances under product code EQJ with a decision year between 1979 and 2017, 1995 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code EQJ by decision year
YearClearances
19791
19801
19892
19941
19958
19962
19981
20041
20171

Applicants with the most clearances

Product code EQJ
Applicants holding the most 510(k) clearances under product code EQJ
ApplicantClearances
Trebay Medical Corp.5
Karl Storz Endoscopy-America, Inc.3
American Sterilizer Co.1
Cmsi1
Gyrus Ent LLC1
Mednext, Inc.1
Medtronic Xomed, Inc.1
Micromedics, Inc.1
Smith & Nephew Richards, Inc.1
Spire Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 76 companies shown, in name order