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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 K260350
Device Name Cysto-Urethroscopes and accessories
Applicant
Hangzhou Hawk Optical Electronic Instruments Co., Ltd.
#9 Xinda Rd., Suoqian, Xiaoshan
Hangzhou,  CN 311201
Applicant Contact Lieqing Zhang
Correspondent
Hangzhou Hawk Optical Electronic Instruments Co., Ltd.
#9 Xinda Rd., Suoqian, Xiaoshan
Hangzhou,  CN 311201
Correspondent Contact Lieqing Zhang
Regulation Number876.1500
Classification Product Code
FJL  
Subsequent Product Codes
FDC   FEC   KQT  
Date Received02/03/2026
Decision Date 10/26/2026
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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