Cleared Traditional

K160523 - BrightMatter Guide with BrightMatter Pointer

K160523 is an FDA 510(k) clearance for BrightMatter Guide with BrightMatter Po..., manufactured by Synaptive Medical, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K160523 · Synaptive Medical, Inc. · Neurology device
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Jun 2016
Decision
120d
Days
Class 2
Risk

K160523 is an FDA 510(k) clearance for the BrightMatter Guide with BrightMatter Pointer. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Synaptive Medical, Inc. (Toronto, CA). The FDA issued a Cleared decision on June 24, 2016 after a review of 120 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 Synaptive Medical, Inc. devices

FDA 510(k) Submission Details - K160523

510(k) Number K160523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2016
Decision Date June 24, 2016
Days to Decision 120 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
29d faster than avg
Panel avg: 149d · This submission: 120d
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.

Regulatory Consultant

Acknowledge Regulatory Strategies
Allison Komiyama

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 387
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K160523.
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