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

    EndoChoice Water Bottle Cap Irrigation System

    K Number: K161482 · Decision Jun 27, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    20
    Applicant Total
    27
    Review Days
    27

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    Basic Information

    Device Name
    EndoChoice Water Bottle Cap Irrigation System
    K Number
    K161482
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Endochoice, Inc.
    Date Received
    May 31, 2016
    Decision Date
    June 27, 2016
    Product Code
    FEQ
    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
    FEQ Pump, Air, Non-Manual, For Endoscope

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    Other Clearances by Endochoice, Inc.

    K Number Device Name
    K160275 Fuse Endoscopic System with FuseBox Processor
    K161167 Seal Single-Use Biopsy Valve
    K160403 SmartStart Air/Water and Suction Valves
    K153588 EndoChoice Water Bottle Cap System
    K151475 EndoChoice Select Injection Needle
    K152182 Fuse Gastroscopy System
    K152580 rescuenet
    K142155 ENDOCHOICE WATER BOTTLE CAP SYSTEM
    K140472 BONASTENT TRACHEAL / BRONCHIAL
    K141598 FUSE COLONOSCOPY SYSTEM
    Search all 27 clearances from Endochoice, Inc. →