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

    SCALP DURA RETRACTOR, MODEL KS00474

    K Number: K093054 · Decision Nov 15, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    42
    Applicant Total
    334
    Review Days
    411

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SCALP DURA RETRACTOR, MODEL KS00474
    K Number
    K093054
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4800
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KARL STORZ Endoscopy-America, Inc.
    Date Received
    September 30, 2009
    Decision Date
    November 15, 2010
    Product Code
    GZT
    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
    GZT Retractor, Self-Retaining, For Neurosurgery

    Similar 510(k) Clearances

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

    Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)

    FDA 510(k)
    FDA Class 2 ·Neurology

    MindsEye Expandable Port

    FDA 510(k)
    FDA Class 2 ·Neurology

    Geister retractor for neuro - and spine surgery

    FDA 510(k)
    FDA Class 2 ·Neurology

    NICO BrainPath

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDICON Spinal Spreading Systems

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by KARL STORZ Endoscopy-America, Inc.

    K Number Device Name
    K252624 KARL STORZ Laryngoscopes and Accessories
    K223923 HOPKINS Telescopes
    K202957 Flexible Video Cysto-Urethroscope (C-view)
    K200318 UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece
    K201135 Image1 S CCU, Image1 S 4U Camera Head
    K200740 HD Video Rhino Laryngoscope
    K191357 Flexible HD Cysto-Urethroscope System
    K182723 Flexible HD Cysto-Urethroscope System
    K182186 CMOS Video-Rhino-Laryngoscope System
    K183264 Flex-THOR scope
    Search all 334 clearances from KARL STORZ Endoscopy-America, Inc. →