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

    Clarus Peel-Away Introducer Sheath

    K Number: K200925 · Decision Mar 18, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    92
    Applicant Total
    10
    Review Days
    345

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    Basic Information

    Device Name
    Clarus Peel-Away Introducer Sheath
    K Number
    K200925
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1480
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clarus Medical, LLC
    Date Received
    April 7, 2020
    Decision Date
    March 18, 2021
    Product Code
    GWG
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GWG Endoscope, Neurological

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    Other Clearances by Clarus Medical, LLC

    K Number Device Name
    K252790 Digital ClarusScope System and Digital NeuroPEN System
    K240535 Digital ClarusScope System; Digital NeuroPEN System
    K223615 Digital ClarusScope System, Digital NeuroPEN System
    K082038 CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V
    K040919 NUCLEOTOME PROBE SET, MODEL 21200
    K040424 LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120
    K022610 CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160
    K021848 CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIBER; MODELS 1150, 1160
    K011454 SPINE SCOPE, MODEL 2180