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FDA 510(k)

ArthroFree Wireless Surgical Camera System

K-Number: K213860 · 2022-03-23

ApplicantLazurite Holdings, LLC
Decision Date2022-03-23
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ArthroFree Wireless Surgical Camera System is a medical device manufactured by Lazurite Holdings, LLC. It received FDA 510(k) clearance on 2022-03-23 under approval number K213860. 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 ArthroFree Wireless Surgical Camera System?

ArthroFree Wireless Surgical Camera System is a medical device that received FDA 510(k) clearance on 2022-03-23. It is manufactured by Lazurite Holdings, LLC. The 510(k) number is K213860.

When was ArthroFree Wireless Surgical Camera System approved by the FDA?

ArthroFree Wireless Surgical Camera System received FDA 510(k) clearance on 2022-03-23, under approval number K213860.

What company makes ArthroFree Wireless Surgical Camera System?

ArthroFree Wireless Surgical Camera System is manufactured by Lazurite Holdings, LLC.

What is the FDA product code for ArthroFree Wireless Surgical Camera System?

The FDA product code for ArthroFree Wireless Surgical Camera System is GCJ.

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

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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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