Claria System
FDA 510(k) clearance DEN250034 · decided 2026-07-02
Clearance details
- K-number
- DEN250034
- Device name
- Claria System
- Applicant
- Claria Medical, Inc.
- Decision
- Unknown
- Date received
- 2025-08-07
- Decision date
- 2026-07-02
- Days to decision
- 329 days
- Clearance type
- Direct
- Product code
- SIM
- Device class
- 2
- Regulation number
- 884.4075
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.