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

Splint, Nasal

21 CFR 874.5800 / Ear, Nose, Throat
FDA source (opens on fda.gov)

EPP is the FDA product code for Splint, Nasal, a class I device type, regulated under 21 CFR 874.5800. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
EPP
Device name
Splint, Nasal
Regulation
21 CFR 874.5800
Device class
Class I
Review panel
Ear, Nose, Throat
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
15
Ingested recalls
2

Clearances, product code EPP

By decision year
15 clearances under product code EPP with a decision year between 1979 and 1994, 1987 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code EPP by decision year
YearClearances
19792
19811
19862
19875
19881
19892
19942

Applicants with the most clearances

Product code EPP
Applicants holding the most 510(k) clearances under product code EPP
ApplicantClearances
Exmoor Plastics Limited4
Xomed, Inc.2
American Silk Sutures, Inc.1
Hood Laboratories1
Microbio-Medics, Inc.1
Micromed Development Corp.1
Microtek Medical LLC1
Richards Medical Co., Inc.1
Ronald D. Shippert, M.D.1
Treace Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 35 companies shown, in name order