Kneevoice Cartilage Evaluation System (750-3600-001)
FDA 510(k) clearance K252076 · decided 2026-02-06
Clearance details
- K-number
- K252076
- Device name
- Kneevoice Cartilage Evaluation System (750-3600-001)
- Applicant
- Kneevoice, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-07-02
- Decision date
- 2026-02-06
- Days to decision
- 219 days
- Clearance type
- Traditional
- Product code
- DQD
- Device class
- 2
- Regulation number
- 870.1875
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Monica, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.