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

Pouch, Colostomy

21 CFR 876.5900 / Gastroenterology, Urology
FDA source (opens on fda.gov)

EZQ is the FDA product code for Pouch, Colostomy, a class I device type, regulated under 21 CFR 876.5900. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
EZQ
Device name
Pouch, Colostomy
Regulation
21 CFR 876.5900
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
6
Ingested recalls
5

Clearances, product code EZQ

By decision year
6 clearances under product code EZQ with a decision year between 1986 and 2011, 2010 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code EZQ by decision year
YearClearances
19861
19881
19921
20102
20111

Applicants with the most clearances

Product code EZQ
Applicants holding the most 510(k) clearances under product code EZQ
ApplicantClearances
ConvaTec Limited3
Boston Pacific Medical, Inc.1
MEDLINE INDUSTRIES, LP - Northfield1
Marlen Mfg. & Development Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 48 companies shown, in name order