BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CHF-Y0005

    K Number: K113120 · Decision Sep 25, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    38
    Applicant Total
    34
    Review Days
    340

    Basic Information

    Device Name
    CHF-Y0005
    K Number
    K113120
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    OLYMPUS MEDICAL SYSTEMS CORP.
    Date Received
    October 21, 2011
    Decision Date
    September 25, 2012
    Product Code
    FBN
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FBN Choledochoscope And Accessories, Flexible/Rigid

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FBN), ordered by most recent decision date.

    Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Biliary Pancreaticobiliary Scope System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Choledochoscope System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by OLYMPUS MEDICAL SYSTEMS CORP.

    K Number Device Name
    K190772 SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
    K172618 SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1
    K170811 Single Use Retrieval Nitinol Basket V
    K172691 Ultrasonic Generator
    K163069 OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
    K153773 Disposal Lens Cleaning Sheath
    K160098 Single Use Aspiration Needle NA-U401SX
    K160241 Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215
    K151743 THUNDERBEAT Open Fine Jaw
    K153625 Single Use Injector NM600/610
    Search all 34 clearances from OLYMPUS MEDICAL SYSTEMS CORP. →