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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K250939
Device Name SIRIUS Endoscope System (PR-SI-1230)
Applicant
Precision Robotics (Hong Kong) Limited
Suite 611-612 Lakeside 2
10w, Hong Kong Science Park, New Territories
Hong Kong,  HK
Applicant Contact Alan Kwok
Correspondent
Vee Care Asia Limited
8/F-1, # 80, Zhouzi St., Neihu District
Taipei City,  TW 114
Correspondent Contact Kacia Mak
Regulation Number884.1720
Classification Product Code
HET  
Subsequent Product Codes
GCJ   GCQ  
Date Received03/28/2025
Decision Date 08/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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