FDA 510(k)

ArthroFree Wireless Surgical Camera System

Numéro K : K213860 · 2022-03-23

Date de décision2022-03-23

Code produitGCJ

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : GCJ)

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Source officielle

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