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FDA 510(k)

Star Tissue Marker

K-Number: K170905 · 2017-04-27

ApplicantScion Medical Technologies, LLC
Decision Date2017-04-27
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Star Tissue Marker is a medical device manufactured by Scion Medical Technologies, LLC. It received FDA 510(k) clearance on 2017-04-27 under approval number K170905. 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 Star Tissue Marker?

Star Tissue Marker is a medical device that received FDA 510(k) clearance on 2017-04-27. It is manufactured by Scion Medical Technologies, LLC. The 510(k) number is K170905.

When was Star Tissue Marker approved by the FDA?

Star Tissue Marker received FDA 510(k) clearance on 2017-04-27, under approval number K170905.

What company makes Star Tissue Marker?

Star Tissue Marker is manufactured by Scion Medical Technologies, LLC.

What is the FDA product code for Star Tissue Marker?

The FDA product code for Star Tissue Marker is NEU.

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K161234CASSI II Rotational Core Biopsy System

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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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