Cleared Traditional

K172006 - Alivio Ventricular Catheter and Flusher...

K172006 is an FDA 510(k) clearance for Alivio Ventricular Catheter and Flusher..., manufactured by Alcyone Lifesciences, Inc.. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K172006 · Alcyone Lifesciences, Inc. · Neurology device
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Nov 2017
Decision
129d
Days
Class 2
Risk

K172006 is an FDA 510(k) clearance for the Alivio Ventricular Catheter and Flusher System (Alivio System). Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Alcyone Lifesciences, Inc. (Lowell, US). The FDA issued a Cleared decision on November 9, 2017 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Alcyone Lifesciences, Inc. devices

FDA 510(k) Submission Details - K172006

510(k) Number K172006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2017
Decision Date November 09, 2017
Days to Decision 129 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 148d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXG Device Classification - Class 2, Special Controls

Product Code JXG Shunt, Central Nervous System And Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
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.

Regulatory Peers - JXG Shunt, Central Nervous System And Components

All 181
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K172006.
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