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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 K250945
Device Name Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)
Applicant
Olympus Medical Systems Corp.
2951 Ishikawa-Cho
Hachiochi-Shi,  JP 192-8507
Applicant Contact Seiko Yunoki
Correspondent
Olympus Corporation of the Americas
800 W Park Dr.
Westborough,  MA  01581
Correspondent Contact Jillian Connery
Regulation Number876.4300
Classification Product Code
KNS  
Date Received03/28/2025
Decision Date 10/17/2025
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
Recalls CDRH Recalls
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