GDS

Bag, Stomal

Product code
GDS
Device name
Bag, Stomal
Device class
Class 1
21 CFR
21 CFR 876.5900
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K) Exempt
510(k) clearances (all years, FDA)
2 (all years; only the last 3 years are listed here)
Official FDA classification page: GDS
Classification and pathway per current FDA publications. Data from openFDA (CC0).