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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Synaptive Medical, Inc.. It received FDA 510(k) clearance on 2016-03-30 under 510(k) 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. The listed applicant is Synaptive Medical, Inc.. The 510(k) number is K153281.

When did BrightMatter Guide with Surface Trace Registration receive FDA 510(k) clearance?

BrightMatter Guide with Surface Trace Registration received FDA 510(k) clearance on 2016-03-30, under 510(k) number K153281.

Who is the listed applicant for BrightMatter Guide with Surface Trace Registration?

The FDA 510(k) record lists Synaptive Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Synaptive Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HAW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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