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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 K250351
Device Name Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)
Applicant
Olympus Medical Systems Corporation
2951 Ishikawa-Cho
Hachioji-Shi
Hachioji-Shi,  JP 192-8507
Applicant Contact Seiki Yunoki
Correspondent
Olympus Surgical Technologies of America
800 W. Park Dr.
Westborough,  MA  01581
Correspondent Contact Susan Lewandowski
Regulation Number876.4300
Classification Product Code
KNS  
Date Received02/07/2025
Decision Date 10/10/2025
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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