BrightMatter Guide with BrightMatter Pointer
K-Number: K160523 · 2016-06-24
ApplicantSynaptive Medical, Inc.
Decision Date2016-06-24
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
BrightMatter Guide with BrightMatter Pointer is a medical device manufactured by Synaptive Medical, Inc.. It received FDA 510(k) clearance on 2016-06-24 under approval number K160523. 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 BrightMatter Pointer?
BrightMatter Guide with BrightMatter Pointer is a medical device that received FDA 510(k) clearance on 2016-06-24. It is manufactured by Synaptive Medical, Inc.. The 510(k) number is K160523.
When was BrightMatter Guide with BrightMatter Pointer approved by the FDA?
BrightMatter Guide with BrightMatter Pointer received FDA 510(k) clearance on 2016-06-24, under approval number K160523.
What company makes BrightMatter Guide with BrightMatter Pointer?
BrightMatter Guide with BrightMatter Pointer is manufactured by Synaptive Medical, Inc..
What is the FDA product code for BrightMatter Guide with BrightMatter Pointer?
The FDA product code for BrightMatter Guide with BrightMatter Pointer is HAW.
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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.