DeviceClearance

Product code EXA— Gastroenterology, Urology

DISC, COLOPLAST PRE-OP STOMA

Classification name
Selector, Size, Ostomy
Device class
Class 1
Regulation
21 CFR 876.5900
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

Market context for product code EXA

FDA has cleared 1 device under product code EXA, all in 1978, filed by 1 applicant company. 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.

Top applicants under product code EXA

Recent clearances under product code EXA

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