510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911349Substantially Equivalent

E-Z-Em Enteroclysis Catheter Set

E-Z-EM, Inc, Westbury NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911349 is the FDA 510(k) clearance record for E-Z-EM ENTEROCLYSIS CATHETER SET, a class II device, cleared for E-Z-Em, Inc. on under FDA product code EZK (Catheter, Retention Type). FDA records list 56 510(k) clearances for E-Z-Em, Inc., from to . As of , FDA records show no recalls naming K911349.

Clearance record

Decision date
Received
(600 days to decision)
Product code
EZK Catheter, Retention Type
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
E-Z-Em, Inc. 717 Main St., Westbury NY
Third party review
No

Clearances, product code EZK

Trailing 12 months

FDA records hold no clearances under product code EZK in the trailing twelve months.

FDA records show no clearances under product code EZK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EZK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260