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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K152511
Device Name Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula
Applicant
Prosurg, Inc.
2193 Trade Zone Blvd.
San Jose,  CA  95131
Applicant Contact ASHVIN DESAI
Correspondent
Prosurg, Inc.
2193 Trade Zone Blvd.
San Jose,  CA  95131
Correspondent Contact ASHVIN DESAI
Regulation Number888.1100
Classification Product Code
HRX  
Date Received09/02/2015
Decision Date 07/11/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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