510(k) clearance

Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Reverse Deflection)

FDA 510(k) source

510(k) number

K260708

Applicant

Vein 360

Decision date

Oct 20, 2026

Date received

Mar 4, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

FGB

Device type

Ureteroscope And Accessories, Flexible/Rigid

Device class

Class II

Regulation

21 CFR 876.1500

Advisory committee

Gastroenterology, Urology

Statement or summary

Summary

Third party

N

Location

Cincinnati, OH, US