Cleared Traditional

BrightMatter Guide with BrightMatter Pointer

K160523 · Synaptive Medical, Inc. · Neurology

Jun 2016

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K160523 is an FDA 510(k) clearance for the BrightMatter Guide with BrightMatter Pointer, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Synaptive Medical, Inc. (Toronto, CA). The FDA issued a Cleared decision on June 24, 2016, 120 days after receiving the submission on February 25, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K160523 FDA.gov
FDA Decision	Cleared 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