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510(k) Data Aggregation

    K Number
    K080674
    Device Name
    PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Date Cleared
    2008-05-09

    (60 days)

    Product Code
    MJG
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    MJG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PAJUNK®'s PrimoCut Disposable Biopsy system is indicated for soft tissue biopsy.
    Device Description
    With PrimoCut. PAJUNK® has developed a disposable cannula system which was especially designed for the extraction of biopsies from soft tissue tumors. Depending on the size of the biopsy material desired, there are two different dissecting lengths to choose from: 6 mm, or 15 mm. Different from the multiple-use biopsy system DeltaCut, the activating mechanism of the PrimoCut is directly integrated in the connecting hub of the cannula. This more economical alternative is disposed of completely after use. The PrimoCut is a semi-automated, spring loaded, sterile disposable device for soft tissue biopsies.
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    K Number
    K070836
    Device Name
    EXICLIP EXCS-M
    Manufacturer
    CLEVEX INC.
    Date Cleared
    2007-04-20

    (24 days)

    Product Code
    MJG, FZQ, GDO
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    MJG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ExiClip™ EXCS-M is intended to provide a biopsy specimen and/or without biopsy under clinical discretion, remove skin lesions less than 6mm in diameter where simultaneous wound closure is desired.
    Device Description
    The ExiClip™ EXCS-M skin biopsy with wound closure device is a single use, disposable device consisting of a removable skin clip, a blade, and a manual delivery system. The device is to be provided sterile. The skin clip is non-absorbable. The skin clip provides wound closure and must be removed after the wound has healed.
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    K Number
    K983647
    Device Name
    ECHO-COAT ULTRASOUND NEEDLES
    Manufacturer
    STS BIOPOLYMERS
    Date Cleared
    1999-01-20

    (96 days)

    Product Code
    MJG
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    MJG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ECHO-COAT™ Ultrasound Needle is indicated for use where improved visibility on ultrasound images is required compared to an uncoated needle. The coated needle also assumes the specific indications for use of the currently marketed uncoated needle, for example biopsy, amniocentesis, vascular access, aspiration, and drainage needles.
    Device Description
    STS Biopolymers, Inc. will purchase in bulk currently marketed needles designated by application (biopsy, aspiration, amniocentesis, etc.), needle type (spinal, Chiba, Franseen, other), needle gauge (11 to 30), and length (3 to 20 cm), and then apply a polymer coating. The coating, called ECHO-COAT™, is visible in ultrasound images, assisting with positioning. The coated needles will be repackaged as single-use devices, sterilized with EtO, and distributed commercially under the STS Biopolymers, Inc. name.
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    K Number
    K955683
    Device Name
    RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY
    Manufacturer
    CONTOUR FABRICATORS OF FLORIDA, INC.
    Date Cleared
    1996-02-01

    (49 days)

    Product Code
    MJG
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    MJG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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