LogoFDA 510(k) Search
Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K041470
    Device Name
    MORTON IUI CATHETERS
    Manufacturer
    FERTILITY TECHNOLOGY RESOURCES, INC.
    Date Cleared
    2004-11-22

    (173 days)

    Product Code
    MQF
    Regulation Number
    884.6110
    Why did this record match?
    Applicant Name (Manufacturer) :

    FERTILITY TECHNOLOGY RESOURCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Insemination Catheters are used for transferring spermatozoa into the uterine cavity.
    Device Description
    Not Found
    Ask a Question
    K Number
    K032208
    Device Name
    MONA LISA ASPIRATION NEEDLE
    Manufacturer
    FERTILITY TECHNOLOGY RESOURCES, INC.
    Date Cleared
    2003-12-09

    (144 days)

    Product Code
    MQE
    Regulation Number
    884.6100
    Why did this record match?
    Applicant Name (Manufacturer) :

    FERTILITY TECHNOLOGY RESOURCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mona Lisa Aspiration Needle is intended for ultrasoundguided, transvaginal recovery and collection of oocytes from ovarian follicles.
    Device Description
    Not Found
    Ask a Question
    K Number
    K023017
    Device Name
    TUCKER EMBRYO CATHETER
    Manufacturer
    FERTILITY TECHNOLOGY RESOURCES, INC.
    Date Cleared
    2002-12-13

    (94 days)

    Product Code
    MQF
    Regulation Number
    884.6110
    Why did this record match?
    Applicant Name (Manufacturer) :

    FERTILITY TECHNOLOGY RESOURCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used for the introduction of embryo(s) into the uterine cavity.
    Device Description
    Not Found
    Ask a Question
    K Number
    K992307
    Device Name
    EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER
    Manufacturer
    FERTILITY TECHNOLOGY RESOURCES, INC.
    Date Cleared
    1999-09-13

    (66 days)

    Product Code
    MQF
    Regulation Number
    884.6110
    Why did this record match?
    Applicant Name (Manufacturer) :

    FERTILITY TECHNOLOGY RESOURCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lifetek Medical Embryo Glide™ Embryo Transfer Catheter is an assisted reproduction catheter used in IVF assisted reproduction procedures to introduce embryo(s) into the female uterus.
    Device Description
    The Embryo Glide™ Embryo Transfer Catheter and accessory stylet (ETC) is used during In-Vitro Fertilization (IVF) procedures to introduce embryo(s) into the female body. The embryo passes through the clear, 5 Fr polyurethane catheter, which is open on the end. The 5 Fr catheter is available in 18 cm and 23 cm lengths. Catheters have color-coded hubs to indicate different lengths. Each ETC comes with a 7 Fr sheath which provides a smooth passage into the uterus. An optional stylet (accessory) is available to aid in the initial placement of the 7 Fr sheath. Both the Embryo Transfer Catheter and stylet accessory (optional) are protected within a polypropylene sheath in a sterile, peel-able pouch.
    Ask a Question

    Page 1 of 1