QIKCAP System
FDA 510(k) clearance DEN250004 · decided 2025-12-23
Clearance details
- K-number
- DEN250004
- Device name
- QIKCAP System
- Applicant
- Hai Solutions
- Decision
- Unknown
- Date received
- 2025-01-30
- Decision date
- 2025-12-23
- Days to decision
- 327 days
- Clearance type
- Direct
- Product code
- SGX
- Device class
- 2
- Regulation number
- 880.6512
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.