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FDA 510(k)

FibermarX Radiopaque Tissue Marker

K-Number: K190155 · 2019-02-27

ApplicantViscus Biologics, LLC
Decision Date2019-02-27
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FibermarX Radiopaque Tissue Marker is a medical device manufactured by Viscus Biologics, LLC. It received FDA 510(k) clearance on 2019-02-27 under approval number K190155. 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 FibermarX Radiopaque Tissue Marker?

FibermarX Radiopaque Tissue Marker is a medical device that received FDA 510(k) clearance on 2019-02-27. It is manufactured by Viscus Biologics, LLC. The 510(k) number is K190155.

When was FibermarX Radiopaque Tissue Marker approved by the FDA?

FibermarX Radiopaque Tissue Marker received FDA 510(k) clearance on 2019-02-27, under approval number K190155.

What company makes FibermarX Radiopaque Tissue Marker?

FibermarX Radiopaque Tissue Marker is manufactured by Viscus Biologics, LLC.

What is the FDA product code for FibermarX Radiopaque Tissue Marker?

The FDA product code for FibermarX Radiopaque Tissue Marker is IYE.

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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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