SmartFlow Neuro Cannula
FDA 510(k) clearance DEN240023 · decided 2024-11-13
Clearance details
- K-number
- DEN240023
- Device name
- SmartFlow Neuro Cannula
- Applicant
- ClearPoint Neuro, Inc.
- Decision
- Unknown
- Date received
- 2024-05-22
- Decision date
- 2024-11-13
- Days to decision
- 175 days
- Clearance type
- Direct
- Product code
- SDG
- Device class
- 2
- Regulation number
- 882.4110
- 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.