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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dislodger, Stone, Biliary
510(k) Number K240192
Device Name Single-use Extraction Baskets
Applicant
Scivita Medical Technology Co., Ltd.
#2, Qingqiu St., Suzhou Industrial Park
Suzhou,  CN 215000
Applicant Contact Wu Ruqin
Correspondent
Scivita Medical Technology Co., Ltd.
#2, Qingqiu St., Suzhou Industrial Park
Suzhou,  CN 215000
Correspondent Contact Dan Jiang
Regulation Number876.5010
Classification Product Code
LQR  
Date Received01/24/2024
Decision Date 10/15/2024
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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