K243708

Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)

510(k) number: K243708
Device name: Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)
Applicant: Scivita Medical Technology Co., Ltd. CN
Product code: FGB — Ureteroscope And Accessories, Flexible/Rigid
Decision date: 2025-03-27
Date received: 2024-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Gastroenterology, Urology

PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K243708.pdf

Official FDA record: K243708

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