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

Tube, Shunt, Endolymphatic

21 CFR 874.3820 / Ear, Nose, Throat
FDA source (opens on fda.gov)

ESZ is the FDA product code for Tube, Shunt, Endolymphatic, a class II device type, regulated under 21 CFR 874.3820. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ESZ
Device name
Tube, Shunt, Endolymphatic
Regulation
21 CFR 874.3820
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code ESZ

By decision year
4 clearances under product code ESZ with a decision year between 1984 and 1998, 1984 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ESZ by decision year
YearClearances
19841
19901
19951
19981

Applicants with the most clearances

Product code ESZ
Applicants holding the most 510(k) clearances under product code ESZ
ApplicantClearances
Exmoor Plastics Limited1
Hood Laboratories1
Treace Medical, Inc.1
Trebay Medical Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code