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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K213860
Device Name ArthroFree Wireless Surgical Camera System
Applicant
Lazurite Holdings, LLC
5000 Euclid Ave., Suite 206
Cleveland,  OH  44103
Applicant Contact Patrick Polito
Correspondent
Mcra, LLC
803 7th St. NW, 3rd Floor
Washington,  DC  20001
Correspondent Contact Mike Goodson
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/10/2021
Decision Date 03/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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