DEN240023 is an FDA 510(k) submission for the SmartFlow Neuro Cannula. This device is classified as a Brain Intraparenchymal Infusion Cannula (Class II - Special Controls, product code SDG).
Submitted by ClearPoint Neuro, Inc. (Solana Beach, US). The FDA issued a Not Cleared (DENG) decision on November 13, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4110. 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) Number | DEN240023 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | May 22, 2024 |
| Decision Date | November 13, 2024 |
| Days to Decision | 175 days |
| Submission Type | Direct |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | SDG - Brain Intraparenchymal Infusion Cannula |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4110 |
| 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. |