K251338

Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)

510(k) number: K251338
Device name: Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)
Applicant: Scivita Medical Technology Co., Ltd. CN
Product code: FBN — Choledochoscope And Accessories, Flexible/Rigid
Decision date: 2026-01-20
Date received: 2025-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Gastroenterology, Urology

PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain

Also available from FDA: K251338.pdf

Official FDA record: K251338

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