SDG · Class II · 21 CFR 882.4110

FDA Product Code SDG: Brain Intraparenchymal Infusion Cannula

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.

Leading manufacturers include ClearPoint Neuro, Inc..

1
Total
0
Cleared
175d
Avg days
2024
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Brain Intraparenchymal Infusion Cannula Devices (Product Code SDG)

1 devices
1–1 of 1
Not Cleared Nov 13, 2024
SmartFlow Neuro Cannula
DEN240023
ClearPoint Neuro, Inc.
Neurology · 175d

About Product Code SDG - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SDG since 2024, with 0 receiving FDA clearance (average review time: 175 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

SDG devices are reviewed by the Neurology panel. Browse all Neurology devices →