BrightMatter Guide with Surface Trace Registration
K-Number: K153281 · 2016-03-30
ApplicantSynaptive Medical, Inc.
Decision Date2016-03-30
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
BrightMatter Guide with Surface Trace Registration is a medical device manufactured by Synaptive Medical, Inc.. It received FDA 510(k) clearance on 2016-03-30 under approval number K153281. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BrightMatter Guide with Surface Trace Registration?
BrightMatter Guide with Surface Trace Registration is a medical device that received FDA 510(k) clearance on 2016-03-30. It is manufactured by Synaptive Medical, Inc.. The 510(k) number is K153281.
When was BrightMatter Guide with Surface Trace Registration approved by the FDA?
BrightMatter Guide with Surface Trace Registration received FDA 510(k) clearance on 2016-03-30, under approval number K153281.
What company makes BrightMatter Guide with Surface Trace Registration?
BrightMatter Guide with Surface Trace Registration is manufactured by Synaptive Medical, Inc..
What is the FDA product code for BrightMatter Guide with Surface Trace Registration?
The FDA product code for BrightMatter Guide with Surface Trace Registration is HAW.
Other Devices by Synaptive Medical, Inc.
Related Devices (Code: HAW)
K162604Cranial Reducing TubesMedtronic Navigation, Inc.
K160811CRW STEREOTACTIC SYSTEMIntegra LifeSciences Corporation
K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc.
K152764EXACTECH GPSBlue Ortho
K160523BrightMatter Guide with BrightMatter PointerSynaptive Medical, Inc.
K151156Fiagon Navigation SystemFiagon GmbH
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.