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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K251923
Device Name Medical Shaver System (Morcellator) (YSB-IIIA)
Applicant
Hangzhou Hawk Optical Electronic Instruments Co., Ltd.
#9,Xinda Rd.,Suoqian,Xiaoshan
Hangzhou,  CN 311201
Applicant Contact Yayan Ding
Correspondent
Hangzhou Hawk Optical Electronic Instruments Co., Ltd.
#9,Xinda Rd.,Suoqian,Xiaoshan
Hangzhou,  CN 311201
Correspondent Contact Yayan Ding
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/23/2025
Decision Date 01/29/2026
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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