Not Cleared Direct

DEN240023 - SmartFlow Neuro Cannula (FDA 510(k) Clearance)

Class II Neurology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN240023 · ClearPoint Neuro, Inc. · Neurology device
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Nov 2024
Decision
175d
Days
Class 2
Risk

DEN240023 is an FDA 510(k) submission (not cleared) for the SmartFlow Neuro Cannula. Classified as Brain Intraparenchymal Infusion Cannula (product code SDG), Class II - Special Controls.

Submitted by ClearPoint Neuro, Inc. (Solana Beach, US). The FDA issued a Not Cleared (DENG) decision on November 13, 2024 after a review of 175 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4110 - the FDA neurology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Neurology review framework.

View all ClearPoint Neuro, Inc. devices

Submission Details

510(k) Number DEN240023 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 22, 2024
Decision Date November 13, 2024
Days to Decision 175 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 148d · This submission: 175d
Pathway characteristics

Device Classification

Product Code SDG Brain Intraparenchymal Infusion Cannula
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4110
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.