510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN240023Unknown

SmartFlow Neuro Cannula

ClearPoint Neuro Inc., Solana Beach CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN240023 is the FDA 510(k) clearance record for SmartFlow Neuro Cannula, a class II device, cleared for ClearPoint Neuro, Inc. on under FDA product code SDG (Brain Intraparenchymal Infusion Cannula). FDA's definition for product code SDG reads: "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". FDA records list 12 510(k) clearances for ClearPoint Neuro, Inc., from to . As of , FDA records show no recalls naming DEN240023.

Clearance record

Decision date
Received
(175 days to decision)
Product code
SDG Brain Intraparenchymal Infusion Cannula
Regulation
21 CFR 882.4110
Device class
Class II
Review panel
Neurology
Applicant
ClearPoint Neuro, Inc. 120 S. Sierra Ave., Suite 100, Solana Beach CA
Third party review
No

Clearances, product code SDG

Trailing 12 months

FDA records hold no clearances under product code SDG in the trailing twelve months.

FDA records show no clearances under product code SDG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SDG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260