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FDA 510(k)

Fusion Bx

K-Number: K153166 · 2016-01-25

ApplicantFocal Healtcare, Inc.
Decision Date2016-01-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Fusion Bx is a medical device manufactured by Focal Healtcare, Inc.. It received FDA 510(k) clearance on 2016-01-25 under approval number K153166. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fusion Bx?

Fusion Bx is a medical device that received FDA 510(k) clearance on 2016-01-25. It is manufactured by Focal Healtcare, Inc.. The 510(k) number is K153166.

When was Fusion Bx approved by the FDA?

Fusion Bx received FDA 510(k) clearance on 2016-01-25, under approval number K153166.

What company makes Fusion Bx?

Fusion Bx is manufactured by Focal Healtcare, Inc..

What is the FDA product code for Fusion Bx?

The FDA product code for Fusion Bx is LLZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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