K250210

Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))

510(k) number: K250210
Device name: Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))
Applicant: Scivita Medical Technology Co., Ltd. CN
Product code: EOQ — Bronchoscope (Flexible Or Rigid)
Decision date: 2025-03-19
Date received: 2025-01-24
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: Ear, Nose, Throat

PDFDownload 510(k) SummaryArchived here · 4.0 MB · U.S. public domain

Also available from FDA: K250210.pdf

Official FDA record: K250210

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