Cleared Traditional

K180854 - Voyager Trajectory Array Guide (V-TAG)

K180854 is an FDA 510(k) clearance for Voyager Trajectory Array Guide (V-TAG), manufactured by Voyager Therapeutics, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K180854 · Voyager Therapeutics, Inc. · Neurology device
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Jul 2018
Decision
112d
Days
Class 2
Risk

K180854 is an FDA 510(k) clearance for the Voyager Trajectory Array Guide (V-TAG). Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Voyager Therapeutics, Inc. (Cambridge, US). The FDA issued a Cleared decision on July 23, 2018 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - 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 Voyager Therapeutics, Inc. devices

FDA 510(k) Submission Details - K180854

510(k) Number K180854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2018
Decision Date July 23, 2018
Days to Decision 112 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 148d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAW Device Classification - Class 2, Special Controls

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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.

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All 265
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