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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K242192
Device Name Disposable Sphincterotome
Applicant
Beijing Zksk Technology Co., Ltd.
Bldg. 9, 6 & #6 Yuan Hengye N. 7th St., Yongle
Economic Development Zone, Tongzhou District
Beijing,  CN 101105
Applicant Contact Li Ma
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lu Jiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number876.4300
Classification Product Code
KNS  
Date Received07/26/2024
Decision Date 02/06/2025
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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