De Novo DEN250043
- Device
- Qoramatic Automated Stool Management
- Contact
- nishith chasmawala
- De Novo number
- DEN250043
- Product code
- SJB
- Regulation
- 876.5230
- Classification name
- powered fecal management system
- Decision
- granted (DENG)
- Decision date
- 2026-08-20
- Date received
- 2025-09-15
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct