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510(k) Data Aggregation

    K Number
    K982630
    Device Name
    MEDWORKS VISUALIZATION INSEMINATION CATHETER
    Manufacturer
    MEDWORKS CORP.
    Date Cleared
    1999-01-14

    (170 days)

    Product Code
    MFD
    Regulation Number
    884.5250
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDWORKS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in intrauterine artificial insemination procedures using washed spermatozoa or semen.
    Device Description
    Malleable catheter with distal side ports and a lumen which can accommodate a fiberoptic device to allow visualization of the interior of the uterus. Allows physician to confirm placement of insemination fluid in the uterine cavity.
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    K Number
    K982628
    Device Name
    MEDWORKS INSEMINATION CATHETER
    Manufacturer
    MEDWORKS CORP.
    Date Cleared
    1998-08-21

    (24 days)

    Product Code
    MFD
    Regulation Number
    884.5250
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDWORKS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in intrauterine artificial insemination procedures using washed spermatozoa or semen.
    Device Description
    Malleable catheter with distal side ports and balloon to help position the catheter at the uterus. Balloon is filled with saline: insemination fluid is introduced using a syringe attached to the proximal luer.
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    K Number
    K982626
    Device Name
    URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0
    Manufacturer
    MEDWORKS CORP.
    Date Cleared
    1998-08-20

    (23 days)

    Product Code
    EZL
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDWORKS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MedWorks Urinary Incontinence Surgical Devices are indicated for use in urethropexy surgical procedures for bladder neck suspension to correct female stress urinary incontinence due to urethral hypermobility.
    Device Description
    The devices described in this 510(k) are surgical procedure kits intended for use in urethropexy procedures, and include components such as suture placement templates, bone anchors, bone drills, syringes, suture retrievers and suture cutters.
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