BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Geister retractor for neuro - and spine surgery

    K Number: K180610 · Decision Aug 29, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    42
    Applicant Total
    6
    Review Days
    174

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    Basic Information

    Device Name
    Geister retractor for neuro - and spine surgery
    K Number
    K180610
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4800
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Geister Medizin Technik GmbH
    Date Received
    March 8, 2018
    Decision Date
    August 29, 2018
    Product Code
    GZT
    Advisory Committee
    Neurology
    Review Advisory Committee
    SU
    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

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    Other Clearances by Geister Medizin Technik GmbH

    K Number Device Name
    K242759 Geister K-Rex rongeurs
    K022823 VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520
    K030788 KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS
    K982365 ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT
    K933699 GEISTER SURGICAL INT'L BIPOLAR ENDOSCOPIC SURGICAL INSTRUMENTS