BrightMatter Guide With BrightMatter Pointer

Neurological Stereotaxic Instrument

SYNAPTIVE MEDICAL INC.

The following data is part of a premarket notification filed by Synaptive Medical Inc. with the FDA for Brightmatter Guide With Brightmatter Pointer.

Pre-market Notification Details

Device IDK160523
510k NumberK160523
Device Name:BrightMatter Guide With BrightMatter Pointer
ClassificationNeurological Stereotaxic Instrument
Applicant SYNAPTIVE MEDICAL INC. MARS CENTER, SOUTH TOWER, 101 COLLEGE STREET, SUITE 200 Toronto,  CA M5g 1l7
ContactCameron Piron
CorrespondentAllison Komiyama
ACKNOWLEDGE REGULATORY STRATEGIES 2834 HAWTHORN ST. San Diego,  CA  92104
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-25
Decision Date2016-06-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00670082000108 K160523 000
00670082000092 K160523 000

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