Clearance Summary
QIKCAP System received FDA 510(k) clearance under submission number DEN250004, sponsored by Hai Solutions. The device was reviewed via the Direct premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2025-12-23.
- Submission: DEN250004
- Applicant / Sponsor: Hai Solutions
- Clearance pathway: Direct
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6512
- Decision date: 2025-12-23
Classification & Regulation
This clearance is catalogued under FDA product code SGX and 21 CFR 880.6512, within the General Hospital review panel as a Class II device.