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510(k) DEN240023

SmartFlow Neuro Cannula by ClearPoint Neuro, Inc. — Product Code SDG

DEN240023 is an FDA 510(k) premarket notification submitted by ClearPoint Neuro, Inc. for the device "SmartFlow Neuro Cannula". The FDA issued a decision of De Novo Granted on November 13, 2024. The device falls under product code SDG (Brain Intraparenchymal Infusion Cannula), a Class II device regulated under 21 CFR 882.4110. ClearPoint Neuro, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
November 13, 2024
Date Received
May 22, 2024
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Brain Intraparenchymal Infusion Cannula
Device Class
Class II
Regulation Number
882.4110
Review Panel
NE
Submission Type

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.

Other clearances by ClearPoint Neuro, Inc.

  • K243657 — ClearPoint System (Software Version 3.0) (January 24, 2025)
  • K233703 — Bone Anchor (NGS-BA-01) (April 26, 2024)
  • K233144 — ClearPoint Bone Screw Fiducials (January 12, 2024)
  • K233155 — ClearPointer Optical Navigation Wand (January 12, 2024)
  • K233141 — SmartFrame OR (January 12, 2024)
  • K233243 — ClearPoint System (Software Version 2.2) (November 27, 2023)
  • K232102 — ClearPoint Array System (Version 1.2) (September 15, 2023)
  • K222519 — ClearPoint System (September 16, 2022)
  • K213645 — ClearPoint Maestro Brain Model (August 8, 2022)
  • K214040 — ClearPoint Array System (version 1.1) (April 12, 2022)

FDA data resources