DeviceClearance

Product code SDG— Neurology

SmartFlow Neuro Cannula

Classification name
Brain Intraparenchymal Infusion Cannula
Device class
Class 2
Regulation
21 CFR 882.4110
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SDG under 21 CFR 882.4110, via openFDA

Market context for product code SDG

FDA has cleared 1 device under product code SDG, all in 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SDG

Recent clearances under product code SDG

Data sourced from openFDA. This site is unofficial and independent of the FDA.