DeviceClearance

Product code GDS— Gastroenterology, Urology

MODIFIED ULTRA-FRESH ODOR REDUCING COMPOUND

Classification name
Bag, Stomal
Device class
Class 1
Regulation
21 CFR 876.5900
Advisory panel
Gastroenterology, Urology
Total cleared
2
First cleared
Most recent

Market context for product code GDS

FDA has cleared 2 devices under product code GDS, all in 1988, 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 GDS

Recent clearances under product code GDS

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