LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    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)
    Manufacturer
    Olympus Medical Systems Corp.
    Date Cleared
    2025-10-17

    (203 days)

    Product Code
    KNS
    Regulation Number
    876.4300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K141991
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC631Q Series are intended to be used for papillotomy using high-frequency current in combination with an endoscope. The preloaded guidewire is used for guiding and exchanging endoscopic accessories for biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts.

    The Single Use Sphincterotome V (Distal Wireguided) KD-VC411Q/VC431Q/VC433Q Series are intended to be used for papillotomy using high-frequency current in combination with an endoscope.

    The Single Use 3-Lumen Sphincterotome V KD-V411M/V431M Series is intended to be used for papillotomy using high-frequency current in combination with an endoscope and guidewire.

    The DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME KD-411Q/431Q Series is intended to be used for papillotomy using high-frequency current in combination with an endoscope.

    Device Description

    The Single Use Sphincterotome KD-VC, KD-V, and KD Series consists of the following devices:

    • Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC600 Series (aka CleverCut3V)
    • Single Use Sphincterotome V (Distal Wireguided) KD-VC400 Series (aka CleverCut3V)
    • Single Use 3-Lumen Sphincterotome V KD-V Series (aka CleverCut3V)
    • DISPOSABLE TRIPLE Lumen SPHINCTEROTOME KD Series (aka FlowCut)

    The subject devices have separate lumens for guidewire, cutting wire and injection of contrast medium for papillotomy. The knives are pre-curved and have a tapered tip to facilitate insertion into the papilla of Vater. The insertion portion of the KD-V, and KD-VC Series have a V-marking, which the relative insertion length into the endoscope can be confirmed by the positional relationship between the V-marking and the biopsy valve of the endoscope and feature an integrated C-Hook to attach to the endoscope. The distal end of the sphincterotome is coated with CleverCut coating ("Olympus' PFA (perfluoroalkoxy) coating designed to prevent thermal injury to non-target tissue while cutting the papilla of Vater. The KD-VC600 Series offers models that are preloaded with VISIGLIDE guidewires.

    The subject devices are provided to the user sterilized by ethylene oxide and intended for single use only.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1