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FDA 510(k)

Radiopaque Tissue Marker

K-Number: K170026 · 2017-06-02

ApplicantViscus Biologics, LLC
Decision Date2017-06-02
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Radiopaque Tissue Marker is a medical device manufactured by Viscus Biologics, LLC. It received FDA 510(k) clearance on 2017-06-02 under approval number K170026. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Radiopaque Tissue Marker?

Radiopaque Tissue Marker is a medical device that received FDA 510(k) clearance on 2017-06-02. It is manufactured by Viscus Biologics, LLC. The 510(k) number is K170026.

When was Radiopaque Tissue Marker approved by the FDA?

Radiopaque Tissue Marker received FDA 510(k) clearance on 2017-06-02, under approval number K170026.

What company makes Radiopaque Tissue Marker?

Radiopaque Tissue Marker is manufactured by Viscus Biologics, LLC.

What is the FDA product code for Radiopaque Tissue Marker?

The FDA product code for Radiopaque Tissue Marker is NEU.

Related Clinical Trials

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Other Devices by Viscus Biologics, LLC

K190155FibermarX Radiopaque Tissue Marker

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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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