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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ultrasonic Surgical
510(k) Number K242894
Device Name SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45)
Applicant
Shanghai Saints Sages Surgical Co., Ltd.
#19, Lane 388, Shengrong Rd., Pilot Free Trade Zone,
Shanghai,  CN 201210
Applicant Contact Xue Ting
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd., Bldg. 1 Suite 300
Austin,  TX  78746
Correspondent Contact Giselle Zhang
Classification Product Code
LFL  
Date Received09/23/2024
Decision Date 06/18/2025
Decision Substantially Equivalent (SESE)
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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