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510(k) Data Aggregation

    K Number
    K241874
    Device Name
    Aspiration Catheter (2189)
    Manufacturer
    Hobbs Medical, Inc.
    Date Cleared
    2024-09-24

    (88 days)

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

    Hobbs Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be utilized by a trained physician through a flexible endoscope for the collection of duodenal or jejunal fluids for diagnostic analysis.
    Device Description
    The Hobbs Medical Aspiration Catheter is a sheath within a sheath design. The inner sheath is actuated using a proximal handle. The inner sheath is protected by an elastomeric membrane that has a slit at the distal end to allow for the inner sheath to advance. The inner sheath has three side holes at the distal tip for collection of aspirate. Once the sample is collected the inner sheath is retracted to protect the sample from contamination as it is withdrawn from the endoscope.
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    K Number
    K182927
    Device Name
    Pulmonary Cytology Brush
    Manufacturer
    Hobbs Medical, Inc.
    Date Cleared
    2020-02-07

    (473 days)

    Product Code
    BTG
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hobbs Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pulmonary Cytology Brush is intended to allow brush sampling of tissue or cells from the upper or lower respiratory tract and/or to perform surveillance cultures
    Device Description
    Not Found
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    K Number
    K093079
    Device Name
    TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U
    Manufacturer
    HOBBS MEDICAL, INC.
    Date Cleared
    2010-08-02

    (306 days)

    Product Code
    KNS
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOBBS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TouchSoft™ Coagulator is used to provide therapeutic hemostasis and tissue ablation in the gastrointestinal tract through a flexible endoscope by a trained physician or clinician.
    Device Description
    Not Found
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    K Number
    K030765
    Device Name
    HOBBS MISTIFIER SPRAY CATHETER
    Manufacturer
    HOBBS MEDICAL, INC.
    Date Cleared
    2003-06-09

    (90 days)

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

    HOBBS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hobbs spray catheter is intended for use as a flexible endoscopic accessory to apply legally marketed solutions for washing or staining mucosal tissue.
    Device Description
    Not Found
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