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

Tray, Irrigation, Sterile

21 CFR 876.5980 / Gastroenterology, Urology
FDA source (opens on fda.gov)

EYN is the FDA product code for Tray, Irrigation, Sterile, a class II device type, regulated under 21 CFR 876.5980. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
EYN
Device name
Tray, Irrigation, Sterile
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
15
Ingested recalls
3

Clearances, product code EYN

By decision year
15 clearances under product code EYN with a decision year between 1977 and 1995, 1979 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code EYN by decision year
YearClearances
19771
19781
19794
19801
19903
19934
19951

Applicants with the most clearances

Product code EYN
Applicants holding the most 510(k) clearances under product code EYN
ApplicantClearances
American Healthcare Corp.4
Orion Life Systems, Inc.2
Bci, Inc.1
Burron Medical Products, Inc.1
Clinical Resources, Inc.1
Intermed, Inc.1
Kit Pak, Inc.1
M-C Ind., Inc.1
Medical Devices Inc.1
Snyder Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code