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510(k) Data Aggregation

    K Number
    K200770
    Device Name
    Mini PCNL-System
    Manufacturer
    Trokamed GmbH
    Date Cleared
    2021-07-30

    (492 days)

    Product Code
    FED, MIN
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Trokamed GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The nephroscopy accessory set is intended for minimally invasive procedures in nephroscopy. The shaft is a reusable, surgically invasive device for shortterm use. It is designed to bring instruments, telescopes, and fluids to the surgical site. The Dilator is a reusable, surgically invasive device for temporary use. It is designed to widen existing surgically invasive openings.
    Device Description
    The TROKAMED GmbH Mini PCNL-System consists of shaft and dilator. The diameter is specified directly on the shaft and dilator. This ensures that the instrument can be assigned easily and only suitable components are used. The instruments cannot be disassembled. The puncture is expanded with the dilator at the beginning of surgery. The procedure, during which kidney stones can be destroyed, is then performed via the shaft. The kidney stones are automatically transported out of the proximal end of the shaft as a result of the cleaning pressure and by the irrigation fluid. The nephroscope may not be fully mounted on the shaft here.
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    K Number
    K091010
    Device Name
    TROKAMED MORCELLATOR
    Manufacturer
    TROKAMED GMBH
    Date Cleared
    2011-03-01

    (691 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    TROKAMED GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TROKAMED MORCELLATOR is a motorized unit for morcellating and extracting tissue during laparoscopic procedures, in general surgery, gynecology including the removal of myomas and hysterectomy, and urology including nephrectomy.
    Device Description
    The TROKAMED MORCELLATOR is comprised of a control unit, a grip module, two foot pedals, a power cord, a control cable and a flexible shaft, in addition to cutting modules, trocar sheaths, trocars, and forceps.
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    K Number
    K060233
    Device Name
    TROKAMED GMBH ENDOSCOPES AND ACCESSORIES
    Manufacturer
    TROKAMED GMBH
    Date Cleared
    2006-07-19

    (170 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    TROKAMED GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The laparoscopes and accessories are intended for use in providing access to and visualization of body cavities, organs, and canals to perform various diagnostic and therapeutic surgical nrocedures . The arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and diagnosis of joint disease in minimally invasive procedures of the knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle and elbow. The cystoscopes and accessories are used for visualizing body cavities and organs (via natural pessages). For examination, diagnosis and for therapy in conjunction with endoscopic accessories / auxiliary instruments through the scope s working channel. The instruments are reusable; they are intended to be cleaned, sterilized and reused.
    Device Description
    The Trokamed GmbH Endoscopes and accessories consist of: - A Various manually operated surgical instruments - A Several Trocar sleeves and accessories, Verres insufflation cannula and suction-firrigation systems - > Several Endoscopes (Arthroscope, Cystoscope)
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    K Number
    K060232
    Device Name
    TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIES
    Manufacturer
    TROKAMED GMBH
    Date Cleared
    2006-07-12

    (163 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    TROKAMED GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trokemed GmbH Resectoscope & accessories are indicated for the resection of prostate tissue. The Trokamed GmbH Monopolar Electrodes are intended for use in minimal invasive techniques where unipolar electrosurgical cutting and coagulation are normally used. The Trokamed GmbH Bipolar Electrodes are intended for use in minimal invasive techniques where bipolar electrosurgical cutting and coagulation are normally used. The instruments are reusable; they are intended to be cleaned sterilized and reused.
    Device Description
    electrosurgical instruments and accessories
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