MARLEN ULTRA ILEOSTOMY POUCH-5000— 510(k) K880327

Name: FDA 510(k) clearance K880327
Creator: U.S. Food and Drug Administration
Published: 1988-02-19

Substantially Equivalent

Marlen Mfg. & Development Co.

FDA 510(k) clearance K880327 for MARLEN ULTRA ILEOSTOMY POUCH-5000, Substantially Equivalent on 1988-02-19. Applicant: Marlen Mfg. & Development Co.. Device class: 1.

Clearance details

Applicant: Marlen Mfg. & Development Co.
Product code: Code EZQ
Device class: Class 1
Regulation: 21 CFR 876.5900
Advisory panel: Gastroenterology, Urology
Date received: 1988-01-26
Decision date: 1988-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, OH, US

Download summary PDF View on FDA.gov ↗

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K102536 — VITALA CONTINENCE CONTROL DEVICE2010-12-01
K083785 — VITALA CONTINENCE CONTROL DEVICE2010-04-02
K922401 — 4 SURE TM COLOSTOMY POUCH1992-06-10
K863830 — CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM1986-10-16

Adverse events under product code EZQ

product code EZQ

Malfunction: 800
Other: 1
Total: 801

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.