FAQ
- Product code
- FAQ
- Device name
- Bag, Urine Collection, Leg, For External Use, Sterile
- Device class
- Class 1
- 21 CFR
- 21 CFR 876.5250
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 18
Official FDA classification page: FAQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).