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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Fistula
510(k) Number K251877
Device Name JMS CAVEO A.V. Fistula Needle Set
Applicant
JMS North America Corporation
22320 Foothill Blvd.
Suite 350
Hayward,  CA  94541
Applicant Contact Sho Hososki
Correspondent
JMS North America Corporation
22320 Foothill Blvd.
Suite 350
Hayward,  CA  94541
Correspondent Contact Sho Hosoki
Regulation Number876.5540
Classification Product Code
FIE  
Date Received06/18/2025
Decision Date 08/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT05493423
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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