De Novo DEN200016
- Device
- EndoRotor Device
- Contact
- jeffery ryan
- De Novo number
- DEN200016
- Product code
- QNE
- Regulation
- 876.4330
- Classification name
- endoscopic pancreatic debridement device
- Decision
- granted (DENG)
- Decision date
- 2020-12-23
- Date received
- 2020-03-16
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- QNE
- Device name
- Endoscopic Pancreatic Debridement Device
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.4330
- Implant
- N
- Life sustain/support
- N