Product code EZR— Gastroenterology, Urology

COLO-TAPE

Classification name
Cement, Stomal Appliance, Ostomy
Device class
Class 1
Regulation
21 CFR 876.5900
Advisory panel
Gastroenterology, Urology
Total cleared
6
First cleared
Most recent

Market context for product code EZR

FDA has cleared 6 devices under product code EZR between 1977 and 1985, filed by 4 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.

Clearances per year

Top applicants under product code EZR

Recent clearances under product code EZR

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