K250573

Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M

510(k) number
K250573
Device name
Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M
Applicant
Olympus Medical Systems Corp. JP
Product code
ODD — Endoscopic Retrograde Cholangiopancreatography (Ercp
Decision date
2025-05-27
Date received
2025-02-26
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain

Also available from FDA: K250573.pdf

Official FDA record: K250573
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.