meddevicedb.com FDA Device Reference

SmartFlow Neuro Cannula

DEN240023 Class II Direct
Decision Date
2024-11-13
Sponsor / Applicant
ClearPoint Neuro, Inc.

Technical Specification

510(k) Submission ID DEN240023
Product Code SDG
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.4110
Decision Date 2024-11-13
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

SmartFlow Neuro Cannula received FDA 510(k) clearance under submission number DEN240023, sponsored by ClearPoint Neuro, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2024-11-13.

Classification & Regulation

This clearance is catalogued under FDA product code SDG and 21 CFR 882.4110, within the Neurology review panel as a Class II device.