SDG

Brain Intraparenchymal Infusion Cannula

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-11-13.

NumberDecision dateApplicantDevice nameSummary
DEN2400232024-11-13ClearPoint Neuro, Inc.SmartFlow Neuro Cannula
Official FDA classification page: SDG
Classification and pathway per current FDA publications. Data from openFDA (CC0).