510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
EPYClass I

Speculum, Ent

21 CFR 878.1800 / General, Plastic Surgery
FDA source (opens on fda.gov)

EPY is the FDA product code for Speculum, Ent, a class I device type, regulated under 21 CFR 878.1800. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
EPY
Device name
Speculum, Ent
Regulation
21 CFR 878.1800
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
12
Ingested recalls
2

Clearances, product code EPY

By decision year
12 clearances under product code EPY with a decision year between 1978 and 1995, 1978 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code EPY by decision year
YearClearances
19784
19791
19823
19841
19851
19931
19951

Applicants with the most clearances

Product code EPY
Applicants holding the most 510(k) clearances under product code EPY
ApplicantClearances
Edward Weck, Inc.3
Treace Medical, Inc.2
Abco Dealers, Inc.1
Downs Surgical, Ltd.1
Imm Enterprises, Ltd.1
Kelleher Corp.1
Pedia Pals, Inc.1
Rudolf Riester GmbH & Co. KG1
Xomed, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 219 companies shown, in name order