DEN250004
- 510(k) number
- DEN250004
- Device name
- QIKCAP System
- Applicant
- Hai Solutions CA · US
- Product code
- SGX — Ultraviolet Light-Based Microbial Reduction Device F
- Decision date
- 2025-12-23
- Date received
- 2025-01-30
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- General Hospital
Official FDA record: DEN250004
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.