K250917

Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8)

510(k) number: K250917
Device name: Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8)
Applicant: Shenzhen Sanping Image Technology Co., Ltd. CN
Product code: FGB — Ureteroscope And Accessories, Flexible/Rigid
Decision date: 2025-10-31
Date received: 2025-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Gastroenterology, Urology

PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain

Also available from FDA: K250917.pdf

Official FDA record: K250917

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