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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ureteroscope And Accessories, Flexible/Rigid
510(k) Number K260708
Device Name Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Reverse Deflection)
Applicant
Vein 360
4460 Lake Forest Dr.
Suite 218
Cincinnati,  OH  45242
Applicant Contact Suzanne Meyer
Correspondent
Vein 360
4460 Lake Forest Dr.
Suite 218
Cincinnati,  OH  45242
Correspondent Contact Suzanne Meyer
Regulation Number876.1500
Classification Product Code
FGB  
Date Received03/04/2026
Decision Date 10/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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