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

Catheter, Retention Type

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

EZK is the FDA product code for Catheter, Retention Type, a class II device type, regulated under 21 CFR 876.5980. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EZK
Device name
Catheter, Retention Type
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
3
Ingested recalls
0

Clearances, product code EZK

By decision year
3 clearances under product code EZK with a decision year between 1977 and 1992, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code EZK by decision year
YearClearances
19771
19901
19921

Applicants with the most clearances

Product code EZK
Applicants holding the most 510(k) clearances under product code EZK
ApplicantClearances
E-Z-EM, Inc1
Howmedica Corp.1
Respiratory Support Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code