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510(k) Data Aggregation

    K Number
    K021438
    Device Name
    INSEMINATION CATHETER, MODEL 320301
    Manufacturer
    LABOTECT LABOR-TECHNIK GOTTINGEN
    Date Cleared
    2002-07-16

    (71 days)

    Product Code
    MFD
    Regulation Number
    884.5250
    Why did this record match?
    Product Code :

    MFD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The catheter is used for intrauterine insemination.
    Device Description
    The Insemination Catheters are used for transferring sperms into the uterine cavity. They have a well rounded tip and two distal side ports. The insemination fluid is introduced using a syringe attached to the proximal luer. The material used in these devices is Polypropylene. Biocompatibility is assured according to ISO 10993.
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    K Number
    K012935
    Device Name
    THECURVE, ITEM 507
    Manufacturer
    SELECT MEDICAL SYSTEMS, INC.
    Date Cleared
    2001-10-11

    (41 days)

    Product Code
    MFD
    Regulation Number
    884.5250
    Why did this record match?
    Product Code :

    MFD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    As the Select IUI® (predicate device), TheCurve™ (new device) is a single use, sterile, disposable, flexible catheter designed to be used for intrauterine artificial insemination.
    Device Description
    TheCurve, such as the Select IUI, comprises a long clear polyethylene tube that is tightly surrounded on three quarters of its proximal length by an outer, clear polypropylene sheath. This leaves 4.5 cm of the inner polyethylene tube exposed at the distal end of the device. The proximal inner tube and outer sheath circumferences are molded directly onto the distal end of a luer lock hub so that only the lumen of the inner tube can provide a channel for flow. This design results in a single-channel catheter with two segments each having different degrees of flexibility. The extreme distal tip of TheCurve™ is open as compared to the extreme distal tip of the Select IUI® which is closed and has two side openings. Both TheCurve and Select IUI have six (6) coloured graduation markings placed at 5, 6, 7, 8, 9, and 10 cm distance from the extreme distal tip of the catheter. The distal portion of TheCurve is curved while the distal portion of the Select IUI is straight.
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    K Number
    K984306
    Device Name
    `THE INSEMINATOR' (PROPOSED)
    Manufacturer
    WALLACH SURGICAL DEVICES, INC.
    Date Cleared
    1999-03-01

    (89 days)

    Product Code
    MFD
    Regulation Number
    884.5250
    Why did this record match?
    Product Code :

    MFD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 'Inseminator' is used for intrauterine artificial insemination procedures utilizing washed spermatozoa or semen. The 'Inseminator' is not intended for intrafallopian tube or in vitro fertilization (IVF) procedures.
    Device Description
    The malleable catheter of Wallach's 'Inseminator' includes the fine, smoothed tip, with a flared proximal end. Insemination fluid (washed sperm) is introduced into the uterine cavity using a syringe attached to the proximal luer.
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    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?
    Product Code :

    MFD

    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?
    Product Code :

    MFD

    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
    K980061
    Device Name
    EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER
    Manufacturer
    ROCKET MEDICAL PLC
    Date Cleared
    1998-03-02

    (54 days)

    Product Code
    MFD
    Regulation Number
    884.5250
    Why did this record match?
    Product Code :

    MFD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EMBRYON® Intra-uterine Insemination Cathetors are purpose designed for the introduction of washed spermatazon into the uterus.
    Device Description
    EMBRYON® Intra-uterine Insemination Catheters
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    K Number
    K972823
    Device Name
    MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER
    Manufacturer
    A & A MEDICAL, INC.
    Date Cleared
    1997-10-10

    (72 days)

    Product Code
    MFD
    Regulation Number
    884.5250
    Why did this record match?
    Product Code :

    MFD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mini Embryon Intrauterine Insemination catheter allows the sperm to bypass the cervix so that an increased number can reach the Uterine cavity and subsequently the fallopian tubes. This catheter is not intended for assisted reproduction procedures.
    Device Description
    The Mini Embryon IUI is a 5Fr Intrauterine Inseminator made of clear polyethylene, 18 cm in length, with an OD of 1.6 mm and an ID of 1.0 mm. A 5 cm distal segment with double side eyes and a rounded tip insures a very smooth entry with minimal disturbance to the endometrial bed. This is complemented with 11 cm of marked catheter shaft with 7 Fr in diameter for better and more secure handling. A proximal Luer Lock allows for connection with a syringe. It is to be supplied in two versions, Soft & Hard.
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    K Number
    K972245
    Device Name
    TOM CAT F.L., TOM CAT S.L.
    Manufacturer
    A & A MEDICAL, INC.
    Date Cleared
    1997-08-06

    (51 days)

    Product Code
    MFD
    Regulation Number
    884.5250
    Why did this record match?
    Product Code :

    MFD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TomCat allows the sperm to bypass the cervix so that an increased number can reach the Uterine cavity and subsequently the fallopian tubes, which may increase the pregnancy rate in couples with unexplained infertility
    Device Description
    The TomCat IUI catheter is a 3 ½ french catheter with a length of 5 ½ ". This catheter expands in size in the proximal area to accommodate a syringe tip. It is made out of propylene of class VI Grade.
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    K Number
    K970750
    Device Name
    MICROSPAN INSEMINATION SYSTEM
    Manufacturer
    IMAGYN MEDICAL, INC.
    Date Cleared
    1997-05-05

    (63 days)

    Product Code
    MFD
    Regulation Number
    884.5250
    Why did this record match?
    Product Code :

    MFD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used for intrauterine insemination. The MicroSpan Delivery Catheter is designed to fit through the larger diameter MicroSpan Access Catheter for delivery of washed spermatozoa to the uterine cavity or for laparoscopic instillation and/or aspiration of media. Laparoscopically, the device is specifically intended for use to aspirate ascitic fluids, aspirate fluid from the cul-de-sac for cytologic screening and bacteriologic cultures, irrigation and aspiration of larger volumes of fluid from ovarian tumors, irrigation and rinsing of the operative field, aspiration of bloody fluid resulting from a tubal pregnancy or post operative bleeding, and instillation of sterile saline or Ringer's solution.
    Device Description
    The MicroSpan Insemination System is a sterile device consisting of two components: the MicroSpan Access Catheter (introducer) and the MicroSpan Delivery Catheter. The MicroSpan Insemination System is designed to be introduced through the MicroSpan Hysteroscope Sheath for intrauterine insemination procedures or introduced through the operative channel of a laparoscope for laparoscopic instillation and/or aspiration of media.
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    K Number
    K964848
    Device Name
    WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM
    Manufacturer
    MARLOW SURGICAL TECHNOLOGIES, INC.
    Date Cleared
    1997-01-16

    (44 days)

    Product Code
    MFD
    Regulation Number
    884.5250
    Why did this record match?
    Product Code :

    MFD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Family of Wallace Artificial Insemination Catheter are sterile single-use device intended for insertion of catheters and introduction of washed spermatozoa into the uterine cavity.
    Device Description
    The Family of Wallace Artificial Insemination Catheter are sterile single-use device intended for insertion of catheters and introduction of washed spermatozoa into the uterine cavity.
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