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

Catheter, Ureteral, Gastro-Urology

21 CFR 876.5130 / Gastroenterology, Urology
FDA source (opens on fda.gov)

EYB is the FDA product code for Catheter, Ureteral, Gastro-Urology, a class II device type, regulated under 21 CFR 876.5130. As of , FDA records hold 28 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
EYB
Device name
Catheter, Ureteral, Gastro-Urology
Regulation
21 CFR 876.5130
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
28
Ingested recalls
4

Clearances, product code EYB

By decision year
28 clearances under product code EYB with a decision year between 1988 and 2020, 1994 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code EYB by decision year
YearClearances
19881
19911
19933
19944
19951
19961
19971
20022
20032
20041
20051
20091
20101
20141
20171
20182
20193
20201

Applicants with the most clearances

Product code EYB
Applicants holding the most 510(k) clearances under product code EYB
ApplicantClearances
Cook Incorporated5
Applied Medical Resources Corp4
MEDLINE INDUSTRIES, LP - Northfield3
Boston Scientific Corporation2
C.R. Bard Inc2
Acmi Corporation1
Amsino International, Inc.1
Applied Urology, Inc.1
Dornier Medtech America, Inc.1
Endooptiks, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 36 companies shown, in name order