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

Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent

21 CFR 878.3500 / General, Plastic Surgery
FDA source (opens on fda.gov)

ESF is the FDA product code for Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent, a class II device type, regulated under 21 CFR 878.3500. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ESF
Device name
Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
Regulation
21 CFR 878.3500
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code ESF

By decision year
2 clearances under product code ESF with a decision year between 1982 and 1989, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ESF by decision year
YearClearances
19821
19891

Applicants with the most clearances

Product code ESF
Applicants holding the most 510(k) clearances under product code ESF
ApplicantClearances
Siemens Hearing Instruments, Inc.1
Xomed, 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 ESF.