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

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..

Clearance details

Applicant: Marlen Mfg. & Development Co.
Product code: Code EZQ
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 ↗

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.