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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K180752
Device Name Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole
Applicant
Corinth Medtech, Inc.
1601 S. De Anza Blvd., Suite 221
Cupertino,  CA  95014
Applicant Contact Sandeep Saboo
Correspondent
Corinth Medtech, Inc.
1601 S. De Anza Blvd., Suite 221
Cupertino,  CA  95014
Correspondent Contact Sandeep Saboo
Regulation Number884.1690
Classification Product Code
HIH  
Subsequent Product Code
HIG  
Date Received03/22/2018
Decision Date 07/25/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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