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

Support, Head, Surgical, Ent

21 CFR 878.4950 / General, Plastic Surgery
FDA source (opens on fda.gov)

EPW is the FDA product code for Support, Head, Surgical, Ent, a class I device type, regulated under 21 CFR 878.4950. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EPW
Device name
Support, Head, Surgical, Ent
Regulation
21 CFR 878.4950
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code EPW

By decision year
2 clearances under product code EPW with a decision year between 1980 and 1982, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code EPW by decision year
YearClearances
19801
19821

Applicants with the most clearances

Product code EPW
Applicants holding the most 510(k) clearances under product code EPW
ApplicantClearances
Med-Life, Inc.1
The Anspach Effort, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code