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

System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile

21 CFR 876.5250 / Gastroenterology, Urology
FDA source (opens on fda.gov)

EYZ is the FDA product code for System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile, a class I device type, regulated under 21 CFR 876.5250. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
EYZ
Device name
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
Regulation
21 CFR 876.5250
Device class
Class I
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
14
Ingested recalls
1

Clearances, product code EYZ

By decision year
14 clearances under product code EYZ with a decision year between 1977 and 1997, 1989 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code EYZ by decision year
YearClearances
19771
19781
19893
19902
19931
19942
19952
19961
19971

Applicants with the most clearances

Product code EYZ
Applicants holding the most 510(k) clearances under product code EYZ
ApplicantClearances
Cypress Medical Products LLC1
Ezmt Valve Co., Inc.1
Goulter Medical, Inc.1
Key Medical Services, Inc.1
Latex Ind., Inc.1
Lsl Industries, Inc.1
MEDLINE INDUSTRIES, LP - Northfield1
P.A.M., Inc.1
Patsy J. Trisler, J.D.1
Researched, Novel Medical Devices (Rn/Md)1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 46 companies shown, in name order