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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K254050
Device Name Manual Tissue Removal Device
Applicant
Suzhou AcuVu Medical Technology Co., Ltd.
B1-212, Bio-Nano Park, 218 Xinghu St.
Suzhou Industrial Park
Suzhou, Jiangsu,  CN 215125
Applicant Contact Sam Mostafavi
Correspondent
Suzhou AcuVu Medical Technology Co., Ltd.
B1-212, Bio-Nano Park, 218 Xinghu St.
Suzhou Industrial Park
Suzhou, Jiangsu,  CN 215125
Correspondent Contact Sam Mostafavi
Regulation Number884.1690
Classification Product Code
HIH  
Date Received12/17/2025
Decision Date 05/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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