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

Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane

21 CFR 874.3620 / Ear, Nose, Throat
FDA source (opens on fda.gov)

ESH is the FDA product code for Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane, a class II device type, regulated under 21 CFR 874.3620. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
ESH
Device name
Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane
Regulation
21 CFR 874.3620
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
1
Ingested recalls
0

Clearances, product code ESH

By decision year
1 clearance under product code ESH with a decision year between 1977 and 1977, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ESH by decision year
YearClearances
19771

Applicants with the most clearances

Product code ESH
Applicants holding the most 510(k) clearances under product code ESH
ApplicantClearances
Coe Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code ESH.