510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880327Substantially Equivalent

Marlen Ultra Ileostomy Pouch-5000

Marlen Mfg. & Development Co., Bedford OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880327 is the FDA 510(k) clearance record for MARLEN ULTRA ILEOSTOMY POUCH-5000, a class I device, cleared for Marlen Mfg. & Development Co. on under FDA product code EZQ (Pouch, Colostomy). FDA records list one 510(k) clearance for Marlen Mfg. & Development Co. As of , FDA records show no recalls naming K880327.

Clearance record

Decision date
Received
(24 days to decision)
Product code
EZQ Pouch, Colostomy
Regulation
21 CFR 876.5900
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Marlen Mfg. & Development Co. 5150 Richmond Rd., Bedford OH
Third party review
No

Clearances, product code EZQ

Trailing 12 months

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

FDA records show no clearances under product code EZQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EZQ, 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