FDA 510(k), K153049, LithoVue System

FDA 510(k), K153049, LithoVue System

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510(K) Number: K153049
Device Name: LithoVue System
Manufacturer: JEANNE O'TOOLE
Device Classification Name: Ureteroscope And Accessories, Flexible/Rigid
Regulation Number: FGB
Classification Product Code: 10/20/2015
Date Received: 11/13/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology

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