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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resectoscope
510(k) Number K230205
Device Name Veloxion System
Applicant
Corinth Medtech, Inc.
1190 Saratoga Ave., Suite 210
San Jose,  CA  95129
Applicant Contact George Hsu
Correspondent
Corinth Medtech, Inc.
1190 Saratoga Ave., Suite 210
San Jose,  CA  95129
Correspondent Contact George Hsu
Regulation Number876.1500
Classification Product Code
FJL  
Subsequent Product Codes
GEI   KQT  
Date Received01/25/2023
Decision Date 02/24/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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