Skip to contentDe Novo DEN190020
- Device
- iTind System
- Contact
- lihi liviatan
- De Novo number
- DEN190020
- Product code
- QKA
- Regulation
- 876.5510
- Classification name
- temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia
- Decision
- granted (DENG)
- Decision date
- 2020-02-25
- Date received
- 2019-04-02
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- QKA
- Device name
- Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.5510
- Implant
- N
- Life sustain/support
- N