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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 K254251
Device Name InnovexView (GC146-17, GC150-20, GC155-23)
Applicant
Shanghai AnQing Medical Instrument Co., Ltd.
3 & 4 Floor, #2 Bldg., 366 Huiqing Rd.
East Zhangjiang High-Tech Park
Shanghai,  CN 201201
Applicant Contact Shuwen Fan
Correspondent
Shanghai AnQing Medical Instrument Co., Ltd.
3 & 4 Floor, #2 Bldg., 366 Huiqing Rd.
East Zhangjiang High-Tech Park
Shanghai,  CN 201201
Correspondent Contact Shuwen Fan
Regulation Number884.1690
Classification Product Code
HIH  
Subsequent Product Code
FAJ  
Date Received12/29/2025
Decision Date 02/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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