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510(k) Data Aggregation

    K Number
    K050135
    Device Name
    K-C HEMOSTATIC BIOPSY SYSTEM
    Date Cleared
    2005-07-13

    (173 days)

    Product Code
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOENGINEERING CONSULTANTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The K-C Hemostatic Biopsy System is indicated for use endoscopically or percutaneous to retrieve tissue sampling of soft organs/tumors or masses for histological analysis and deliver a hemostatic material to the biopsy site to reduce bleeding from the biopsy site. Soft tissue sampling includes but not limited to organs such as breast, liver, kidney and prostate. It is not intended for use in bone.
    Device Description
    The proposed device consists of a mechanism to capture a biopsy sample of soft tissue, soft organs, tumor or masses for histological analysis and a co-axially configured syringe containing a hemostatic agent to be delivered into the biopsy tract upon removal of the biopsy sample.
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