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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 K241956
Device Name Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)
Applicant
Hunan Endoso Life Technology Co., Ltd.
4th Floor, Bldg. 10, Innovation And Entrepreneurship
Center, 31 Dongfeng Rd., Heping St., Xiangtan Economic
Xiangtan,  CN 411199
Applicant Contact Fu Wang
Correspondent
Landlink Healthcare Technology (Shanghai) Co., Ltd.
Rm. 1308, Baohua International Plaza,
West Guangzhong Rd. 555, Jingan District
Shanghai,  CN 200000
Correspondent Contact Eric Zhang
Regulation Number876.1500
Classification Product Code
FGB  
Date Received07/03/2024
Decision Date 01/22/2025
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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