FDA 510(k)

BioZorb Marker GOLD / LP Marker GOLD

K-Number: K171467 · 2017-11-09

Decision Date2017-11-09

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BioZorb Marker GOLD / LP Marker GOLD is a medical device manufactured by Focal Therapeutics. It received FDA 510(k) clearance on 2017-11-09 under approval number K171467. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioZorb Marker GOLD / LP Marker GOLD?

BioZorb Marker GOLD / LP Marker GOLD is a medical device that received FDA 510(k) clearance on 2017-11-09. It is manufactured by Focal Therapeutics. The 510(k) number is K171467.

When was BioZorb Marker GOLD / LP Marker GOLD approved by the FDA?

BioZorb Marker GOLD / LP Marker GOLD received FDA 510(k) clearance on 2017-11-09, under approval number K171467.

What company makes BioZorb Marker GOLD / LP Marker GOLD?

BioZorb Marker GOLD / LP Marker GOLD is manufactured by Focal Therapeutics.

What is the FDA product code for BioZorb Marker GOLD / LP Marker GOLD?

The FDA product code for BioZorb Marker GOLD / LP Marker GOLD is IYE.

Other Devices by Focal Therapeutics

K192371BioZorb SP Marker

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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.