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FDA 510(k)

Radiance Ultra Series ZeroWire Embedded

K-Number: K161228 · 2016-05-26

ApplicantNds Surgical Imaging, LLC
Decision Date2016-05-26
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Radiance Ultra Series ZeroWire Embedded is a medical device manufactured by Nds Surgical Imaging, LLC. It received FDA 510(k) clearance on 2016-05-26 under approval number K161228. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Radiance Ultra Series ZeroWire Embedded?

Radiance Ultra Series ZeroWire Embedded is a medical device that received FDA 510(k) clearance on 2016-05-26. It is manufactured by Nds Surgical Imaging, LLC. The 510(k) number is K161228.

When was Radiance Ultra Series ZeroWire Embedded approved by the FDA?

Radiance Ultra Series ZeroWire Embedded received FDA 510(k) clearance on 2016-05-26, under approval number K161228.

What company makes Radiance Ultra Series ZeroWire Embedded?

Radiance Ultra Series ZeroWire Embedded is manufactured by Nds Surgical Imaging, LLC.

What is the FDA product code for Radiance Ultra Series ZeroWire Embedded?

The FDA product code for Radiance Ultra Series ZeroWire Embedded is GCJ.

Related Clinical Trials

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Other Devices by Nds Surgical Imaging, LLC

K170598ZeroWire Mobile K222890RADIANCE ULTRA 32 4K ZEROWIRE DUO

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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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