DEN240023
- 510(k) number
- DEN240023
- Device name
- SmartFlow Neuro Cannula
- Applicant
- ClearPoint Neuro, Inc. CA · US
- Product code
- SDG — Brain Intraparenchymal Infusion Cannula
- Decision date
- 2024-11-13
- Date received
- 2024-05-22
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Neurology
Official FDA record: DEN240023
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.