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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 the device name listed in this FDA 510(k) record. The listed applicant is Nds Surgical Imaging, LLC. It received FDA 510(k) clearance on 2016-05-26 under 510(k) 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. The listed applicant is Nds Surgical Imaging, LLC. The 510(k) number is K161228.

When did Radiance Ultra Series ZeroWire Embedded receive FDA 510(k) clearance?

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

Who is the listed applicant for Radiance Ultra Series ZeroWire Embedded?

The FDA 510(k) record lists Nds Surgical Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Nds Surgical Imaging, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222890RADIANCE ULTRA 32 4K ZEROWIRE DUOK170598ZeroWire Mobile

Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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