RADIANCE ULTRA 32 4K ZEROWIRE DUO
K-Number: K222890 · 2022-10-19
ApplicantNds Surgical Imaging, LLC
Decision Date2022-10-19
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
RADIANCE ULTRA 32 4K ZEROWIRE DUO is a medical device manufactured by Nds Surgical Imaging, LLC. It received FDA 510(k) clearance on 2022-10-19 under approval number K222890. 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 32 4K ZEROWIRE DUO?
RADIANCE ULTRA 32 4K ZEROWIRE DUO is a medical device that received FDA 510(k) clearance on 2022-10-19. It is manufactured by Nds Surgical Imaging, LLC. The 510(k) number is K222890.
When was RADIANCE ULTRA 32 4K ZEROWIRE DUO approved by the FDA?
RADIANCE ULTRA 32 4K ZEROWIRE DUO received FDA 510(k) clearance on 2022-10-19, under approval number K222890.
What company makes RADIANCE ULTRA 32 4K ZEROWIRE DUO?
RADIANCE ULTRA 32 4K ZEROWIRE DUO is manufactured by Nds Surgical Imaging, LLC.
What is the FDA product code for RADIANCE ULTRA 32 4K ZEROWIRE DUO?
The FDA product code for RADIANCE ULTRA 32 4K ZEROWIRE DUO is GCJ.
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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.