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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 K262552
Device Name Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)
Applicant
Scivita Medical Technology Co., Ltd.
# 2, Qingqiu St., Suzhou Industrial Park
Suzhou,  CN 215000
Applicant Contact Wu Ruqin
Correspondent
Scivita Medical Technology Co., Ltd.
# 2, Qingqiu St., Suzhou Industrial Park
Suzhou,  CN 215000
Correspondent Contact Mengxuan Yuan
Regulation Number876.1500
Classification Product Code
FGB  
Date Received07/24/2026
Decision Date 08/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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