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510(k) Data Aggregation

    K Number
    K023450
    Device Name
    BIOPSY SITE TISSUE MARKER DEVICE
    Manufacturer
    PROMEX, INC.
    Date Cleared
    2002-12-19

    (65 days)

    Product Code
    NEU
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROMEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These devices are intended to be used to mark an open or These devices are incended to be assabically mark the location of the biopsy site.
    Device Description
    Not Found
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    K Number
    K022634
    Device Name
    CO-AXIAL INTRODUCER NEEDLE
    Manufacturer
    PROMEX, INC.
    Date Cleared
    2002-11-06

    (90 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROMEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be used for percutaneous transjugular li access during diagnostic and interventional procedures.
    Device Description
    Co-Axial Introducer Needle; Co-Axial Introducer Set/Transjugular Liver Access Set
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    K Number
    K010400
    Device Name
    VACUUM ASSISTED CORE BIOPSY DEVICE
    Manufacturer
    PROMEX, INC.
    Date Cleared
    2001-07-24

    (162 days)

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

    PROMEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K011270
    Device Name
    AUTOMATED CORE BIOPSY DEVICE
    Manufacturer
    PROMEX, INC.
    Date Cleared
    2001-06-22

    (57 days)

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

    PROMEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001132
    Device Name
    BONE BIOPSY NEEDLE
    Manufacturer
    PROMEX, INC.
    Date Cleared
    2000-05-01

    (21 days)

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

    PROMEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994272
    Device Name
    AUTOMATED CORE BIOPSY DEVICE
    Manufacturer
    PROMEX, INC.
    Date Cleared
    2000-01-07

    (18 days)

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

    PROMEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To obtain percutaneous core biopsy samples from soft tissue 10 obtain perculations core bropsy surves, kidney, prostate, and culturs of sach organs as awnen used for breast blopsy, the product is for diagnosis only.
    Device Description
    Automated Core Biopsy Device
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    K Number
    K993435
    Device Name
    MANUAL BONE MARROW BIOPSY DEVICE
    Manufacturer
    PROMEX, INC.
    Date Cleared
    1999-12-06

    (55 days)

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

    PROMEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These devices are intended to be used to obtain percutaneous biopsy samples of Bone Marrow.
    Device Description
    A. Intended Use: These devices are intended to be used to obtain percutaneous biopsy samples of Bone Marrow. B. Materials: 304 Stainless Steel and polycarbonate or similar material. For more detail about materials refer to Section I - Attachments A. C. Additional Features: Currently, Manan (Northbrook, IL) provides features such as: Luer fittings on Cannula and adjustable depth stop (Illinois style). Promex's products will incorporate these features as well. A listing of available needle dimensions is included in Section I - Attachment B.
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    K Number
    K973184
    Device Name
    PROSTATE SEEDING NEEDLE
    Manufacturer
    PROMEX, INC.
    Date Cleared
    1997-11-21

    (88 days)

    Product Code
    IWJ
    Regulation Number
    892.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROMEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the manual application of a radionuclide source into the body for radiation therapy.
    Device Description
    Prostate Seeding Needle
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    K Number
    K972865
    Device Name
    PROMEX ENT TISSUE REMOVAL SYSTEM
    Manufacturer
    PROMEX, INC.
    Date Cleared
    1997-09-29

    (56 days)

    Product Code
    ERL
    Regulation Number
    874.4250
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROMEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the removal of soft tissue and bone in the ear, nose & throat.
    Device Description
    Promex ENT Tissue Removal System
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    K Number
    K961078
    Device Name
    AUTOMATED VITRECTOMY DEVICE
    Manufacturer
    PROMEX, INC.
    Date Cleared
    1996-06-14

    (88 days)

    Product Code
    HQE
    Regulation Number
    886.4150
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROMEX, INC.

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

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