SDG
- Product code
- SDG
- Device name
- Brain Intraparenchymal Infusion Cannula
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.4110
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 0 (direct download)
- 510(k) clearances (all years, FDA)
- 1 (all years; only the last 3 years are listed here)
FDA classification definition
A brain intraparenchymal infusion cannula is a non-powered, hollow tube-like device with a rigid component for stereotaxic-aided temporary placement in brain parenchyma tissue to deliver a therapy.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| DEN240023 | 2024-11-13 | ClearPoint Neuro, Inc. | SmartFlow Neuro Cannula | — |
Official FDA classification page: SDG
Classification and pathway per current FDA publications. Data from openFDA (CC0).