ClearPoint System (Software Version 3.0)
FDA 510(k) clearance K243657 · decided 2025-01-24
Clearance details
- K-number
- K243657
- Device name
- ClearPoint System (Software Version 3.0)
- Applicant
- ClearPoint Neuro, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-11-27
- Decision date
- 2025-01-24
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Solana Beach, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.