De Novo DEN230019
- Device
- AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent)
- Contact
- alexis erazo
- De Novo number
- DEN230019
- Product code
- QXH
- Regulation
- 876.5016
- Classification name
- gallbladder drainage stent and delivery system
- Decision
- granted (DENG)
- Decision date
- 2023-08-18
- Date received
- 2023-03-27
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- QXH
- Device name
- Gallbladder Drainage Stent And Delivery System
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.5016
- Implant
- Y
- Life sustain/support
- N