Livi Device
FDA 510(k) clearance K252005 · decided 2026-03-20
Clearance details
- K-number
- K252005
- Device name
- Livi Device
- Applicant
- Liviwell, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-06-27
- Decision date
- 2026-03-20
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- HEB
- Device class
- 2
- Regulation number
- 884.5470
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mountain Lakes, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.