Not Cleared Direct

DEN170064 - Comaneci, Comaneci Petit, Comaneci 17 (FDA 510(k) Clearance)

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

DEN170064 · Rapid Medical , Ltd. · Neurology device
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Apr 2019
Decision
573d
Days
Class 2
Risk

DEN170064 is an FDA 510(k) submission (not cleared) for the Comaneci, Comaneci Petit, Comaneci 17. Classified as Temporary Coil Embolization Assist Device (product code PUU), Class II - Special Controls.

Submitted by Rapid Medical , Ltd. (Yokneam, IL). The FDA issued a Not Cleared (DENG) decision on April 24, 2019 after a review of 573 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5955 - 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: Regulatory edge-case submission. High predicate equivalence gap. With 573 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Rapid Medical , Ltd. devices

Submission Details

510(k) Number DEN170064 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 28, 2017
Decision Date April 24, 2019
Days to Decision 573 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
425d slower than avg
Panel avg: 148d · This submission: 573d
Pathway characteristics

Device Classification

Product Code PUU Temporary Coil Embolization Assist Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5955
Definition A Temporary Coil Embolization Assist Device Is A Prescription Device Intended For Temporary Use In The Neurovasculature To Mechanically Assist In The Embolization Of Intracranial Aneurysms With Embolic Coils. The Device Is Delivered Into The Neurovasculature With An Endovascular Approach. This Device Is Not Intended To Be Permanently Implanted And Is Removed From The Body When The Procedure Is Completed.
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.