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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 the device name listed in this FDA 510(k) record. The listed applicant is Lazurite Holdings, LLC. It received FDA 510(k) clearance on 2022-03-23 under 510(k) 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. The listed applicant is Lazurite Holdings, LLC. The 510(k) number is K213860.

When did ArthroFree Wireless Surgical Camera System receive FDA 510(k) clearance?

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

Who is the listed applicant for ArthroFree Wireless Surgical Camera System?

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

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

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

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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