De Novo DEN250004
- Device
- QIKCAP System
- Contact
- brittany batts
- De Novo number
- DEN250004
- Product code
- SGX
- Regulation
- 880.6512
- Classification name
- ultraviolet light-based microbial reduction device for luer-activated valves
- Decision
- granted (DENG)
- Decision date
- 2025-12-23
- Date received
- 2025-01-30
- Classification advisory
- General Hospital
- Review advisory
- General Hospital
- Type
- Direct
Current FDA Classification
- Product code
- SGX
- Device name
- Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation
- 880.6512
- Implant
- N
- Life sustain/support
- N