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

Stylet For Catheter, Gastro-Urology

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

EZB is the FDA product code for Stylet For Catheter, Gastro-Urology, a class I device type, regulated under 21 CFR 876.5130. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 13 recalls.

Classification record

Product code
EZB
Device name
Stylet For Catheter, Gastro-Urology
Regulation
21 CFR 876.5130
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
3
Ingested recalls
13

Clearances, product code EZB

By decision year
3 clearances under product code EZB with a decision year between 1987 and 1997, 1997 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code EZB by decision year
YearClearances
19871
19972

Applicants with the most clearances

Product code EZB
Applicants holding the most 510(k) clearances under product code EZB
ApplicantClearances
Applied Medical Resources Corp1
Endovations1
Lake Region Mfg., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 38 companies shown, in name order