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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ureteroscope And Accessories, Flexible/Rigid
510(k) Number K243894
Device Name F88 URE-SD/RD Flexible Ureteroscope
Applicant
Sg Endoscopy Pte, Ltd.
79 Loyang Way
N/A,  SG 508766
Applicant Contact John Yeng Jie Woo
Correspondent
Eliquent Life Sciences
1055 Thomas Jefferson St., Suite 450
Washington,  DC  20007
Correspondent Contact Samantha Eakes
Regulation Number876.1500
Classification Product Code
FGB  
Date Received12/18/2024
Decision Date 05/02/2025
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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