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510(k) Data Aggregation

    K Number
    K180610
    Device Name
    Geister retractor for neuro - and spine surgery
    Manufacturer
    Geister Medizintechnik GmbH
    Date Cleared
    2018-08-29

    (174 days)

    Product Code
    GZT
    Regulation Number
    882.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Geister Medizintechnik GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device intended for use as a specialized manual surgical instrument. It is reusable and intended to provide access to the thoracic and lumbar spinal column during minimally invasive and endoscopic surgical provides a selflocking type surgical retraction system with inflatable tissue protectors.
    Device Description
    GEISTER Medizintechnik GmbH Self-retaining Retractors are reusable manual instruments made from stainless steel, PEEK or titanium. They are sold unsterile and can be re-processed according the instructions for use.
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    K Number
    K022823
    Device Name
    VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520
    Manufacturer
    GEISTER MEDIZINTECHNIK GMBH
    Date Cleared
    2004-07-01

    (675 days)

    Product Code
    MGZ
    Regulation Number
    870.4885
    Why did this record match?
    Applicant Name (Manufacturer) :

    GEISTER MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Geister Valvulotomeare designed to incise the valve cusps of the graft in coronary artery bypass graft (CABG) procedures.
    Device Description
    Not Found
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    K Number
    K030788
    Device Name
    KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS
    Manufacturer
    GEISTER MEDIZINTECHNIK GMBH
    Date Cleared
    2003-07-12

    (122 days)

    Product Code
    DWP
    Regulation Number
    870.4475
    Why did this record match?
    Applicant Name (Manufacturer) :

    GEISTER MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GEISTER vessel dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.
    Device Description
    GEISTER vessel dilators
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    K Number
    K982365
    Device Name
    ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT
    Manufacturer
    GEISTER MEDIZINTECHNIK GMBH
    Date Cleared
    1999-04-08

    (275 days)

    Product Code
    DXC, SCU
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    GEISTER MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To temporarily occlude an artery or vein with correct tension to produce minimal trauma to vessels. The different sizes and models are designed according to the type and size of the blood vessels, anatomical sites, and surgical techniques. Bulldog clamps are self-closing and are used for small vessels. The closing pressure of the GLOVER clamps can be adjusted using a nut and spring. Applying forceps are used to apply bulldog clamps in deep surgical wounds. To secure vascular occlusion of small vessels during surgery and to secure vascular occlusion during pediatric surgery.
    Device Description
    Not Found
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