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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ureteroscope And Accessories, Flexible/Rigid
510(k) Number K211686
Device Name Flexible Video-Choledo-Cysto-Ureteroscope System
Applicant
Shanghai SeeGen Photoelectric Technology Co., Ltd.
3 Floor, Bldg. #1, 4299 Jindu Rd., Minhang District
Shanghai,  CN 201108
Applicant Contact Yvonne Fei
Correspondent
Shanghai Vanhe Consulting Co., Ltd.
2f, Bldg. #1, 3938 Huqingping Rd.
Shanghai,  CN 201713
Correspondent Contact Nick Wang
Regulation Number876.1500
Classification Product Code
FGB  
Subsequent Product Codes
FBN   KQM  
Date Received06/02/2021
Decision Date 02/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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