Skip to contentDe Novo DEN250023
- Device
- Aurie System
- Contact
- souvik paul
- De Novo number
- DEN250023
- Product code
- SHV
- Regulation
- 876.5120
- Classification name
- reusable intermittent urinary catheter system
- Decision
- granted (DENG)
- Decision date
- 2026-04-30
- Date received
- 2025-06-06
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- SHV
- Device name
- Reusable Intermittent Urinary Catheter System
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.5120
- Implant
- N
- Life sustain/support
- N