Brain Intraparenchymal Infusion Cannula
A brain intraparenchymal infusion cannula is a non-powered, hollow tube-like neurological device with a rigid component for stereotaxic-aided temporary placement in brain parenchyma tissue to deliver therapeutic agents directly into the brain, enabling targeted intracranial drug delivery. It is classified as FDA Class II (510(k) required) under regulation 882.4110 in the Neurology specialty, with product code SDG. The device is not an implant (temporary placement only) and does not support life-sustaining functions.
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Basic Information
- Product Code
- SDG
- Device Class
- FDA class 2
- Regulation Number
- 882.4110
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
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) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN240023 | SmartFlow Neuro Cannula | Nov 13, 2024 | Unknown | ClearPoint Neuro, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.