SDG — Brain Intraparenchymal Infusion Cannula Class II
FDA product code SDG covers "Brain Intraparenchymal Infusion Cannula", a Class II medical device regulated under 21 CFR 882.4110. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SDG
- Device Class
- Class II
- Regulation Number
- 882.4110
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN240023 | clearpoint neuro | SmartFlow Neuro Cannula | November 13, 2024 |