510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
EZNClass II

Dilator, Catheter, Ureteral

21 CFR 876.5470 / Gastroenterology, Urology
FDA source (opens on fda.gov)

EZN is the FDA product code for Dilator, Catheter, Ureteral, a class II device type, regulated under 21 CFR 876.5470. As of , FDA records hold 56 510(k) clearances under this code, the most recent dated , and 14 recalls.

Classification record

Product code
EZN
Device name
Dilator, Catheter, Ureteral
Regulation
21 CFR 876.5470
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
56
Ingested recalls
14

Clearances, product code EZN

By decision year
56 clearances under product code EZN with a decision year between 1981 and 2025, 1985 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code EZN by decision year
YearClearances
19811
19831
19844
19855
19872
19892
19902
19915
19924
19945
19954
19961
19971
19981
19991
20001
20031
20041
20052
20061
20132
20171
20184
20191
20201
20231
20251

Applicants with the most clearances

Product code EZN
Applicants holding the most 510(k) clearances under product code EZN
ApplicantClearances
Boston Scientific Corporation9
Cook Incorporated9
American Edwards Laboratories5
Van-Tec, Inc.4
American Medical Systems, Inc.3
C.R. Bard Inc3
Meadox Medicals, Div. Boston Scientific Corp.3
Meadox Surgimed, Inc.3
MEDLINE INDUSTRIES, LP - Northfield2
Onset Medical Corporation2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order