K250945

Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)

510(k) number: K250945
Device name: Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)
Applicant: Olympus Medical Systems Corp. JP
Product code: KNS — Unit, Electrosurgical, Endoscopic (With Or Without A
Decision date: 2025-10-17
Date received: 2025-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Gastroenterology, Urology

PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain

Also available from FDA: K250945.pdf

Official FDA record: K250945

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