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

Tack, Sacculotomy (Cody Tack)

21 CFR 874.3760 / Ear, Nose, Throat
FDA source (opens on fda.gov)

ESX is the FDA product code for Tack, Sacculotomy (Cody Tack), a class II device type, regulated under 21 CFR 874.3760. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
ESX
Device name
Tack, Sacculotomy (Cody Tack)
Regulation
21 CFR 874.3760
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 ESX

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

Applicants with the most clearances

Product code ESX
Applicants holding the most 510(k) clearances under product code ESX
ApplicantClearances
Micromedics, 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 ESX.