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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 K241855
Device Name SB Knife Jr2 (MD-47702 and MD-47702L)
Applicant
Sb-Kawasumi Laboratories, Inc.
3-15-4 Tonomachi, Kawasaki-Ku
Kawasaki-Shi,  JP 210-8602
Applicant Contact Kenichi Inamura
Correspondent
Mic International
4-32-16 Ryogoku
Sumida-Ku,  JP 130-0026
Correspondent Contact Fumiaki Kanai
Regulation Number876.4300
Classification Product Code
KNS  
Date Received06/27/2024
Decision Date 03/26/2025
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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