Product code EZQ— Gastroenterology, Urology

FDA has cleared 6 devices under product code EZQ between 1986 and 2011, filed by 5 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20111 clearance
• 20102 clearances
• 19921 clearance
• 19881 clearance
• 19861 clearance

• Convatec, Inc.2 clearances
• Marlen Mfg. & Development Co.1 clearance
• Convatec1 clearance
• Coloplast A/S1 clearance
• Boston Pacific Medical, Inc.1 clearance

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 →

• K111365 — VITALA CONTINENCE CONTROL DEVICEConvatec, Inc.·2011-08-19
• K102536 — VITALA CONTINENCE CONTROL DEVICEConvatec, Inc.·2010-12-01
• K083785 — VITALA CONTINENCE CONTROL DEVICEConvatec·2010-04-02
• K922401 — 4 SURE TM COLOSTOMY POUCHBoston Pacific Medical, Inc.·1992-06-10
• K880327 — MARLEN ULTRA ILEOSTOMY POUCH-5000Marlen Mfg. & Development Co.·1988-02-19
• K863830 — CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEMColoplast A/S·1986-10-16