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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 K243807
Device Name Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P
Applicant
Olympus Medical Systems Corp.
2951 Ishikawa-Cho
Hachiochi-Shi,  JP 192-0032
Applicant Contact Seiko Yunoki
Correspondent
Olympus Corporation of the Americas
800 W Park Dr.
Westborough,  MA  01581
Correspondent Contact Roshana Ahmed
Regulation Number876.5010
Classification Product Code
LQR  
Subsequent Product Code
OCZ  
Date Received12/11/2024
Decision Date 03/18/2025
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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