K252703

LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)

510(k) number: K252703
Device name: LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)
Applicant: Boston Scientific Corporation MA · US
Product code: FGB — Ureteroscope And Accessories, Flexible/Rigid
Decision date: 2025-09-24
Date received: 2025-08-27
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: Gastroenterology, Urology

PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain

Also available from FDA: K252703.pdf

Official FDA record: K252703

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.