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510(k) Data Aggregation

    K Number
    K041094
    Device Name
    HSG CATHETER SET
    Manufacturer
    BIOTEQUE AMERICA, INC.
    Date Cleared
    2004-06-17

    (51 days)

    Product Code
    LKF
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOTEQUE AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bioteque's HSG catheter sets are indicated to evaluate the causes of abnormal uterine bleeding, menstrual disorders, recurring pregnancy loss, or unexplained infertility. They can also be used to assess uterine pathology and patients on tamoxifan therapy. HSG type catheter sets are used to infuse a fluid (either a contrast media or a sterile saline) into the uterine cavity while blocking the external cervical OS to retain the fluid in the uterus during the procedure.
    Device Description
    Not Found
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    K Number
    K020628
    Device Name
    CURELLE, PREFERRED CURELLE, CUTEQ 2.5
    Manufacturer
    BIOTEQUE AMERICA, INC.
    Date Cleared
    2002-05-24

    (87 days)

    Product Code
    HHK
    Regulation Number
    884.1175
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOTEQUE AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An endometrial suction curette, such as Bioteque's Curelle, Preferved Corelle, or Coteq 2.5, are devices used to remove samples of materials from the uterus and from the mucosal lining of thee uterus by scraping or vacuum suction These devices obtain tissue samples for purpos of biopsy & precancer screening or they can be used for menstrual extraction.
    Device Description
    An endometrial suction curette, such as Bioteque's Curelle, Preferved Corelle, or Coteq 2.5
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    K Number
    K013289
    Device Name
    BIOTEQUE VAGINAL PESSARIES
    Manufacturer
    BIOTEQUE AMERICA, INC.
    Date Cleared
    2001-12-27

    (86 days)

    Product Code
    HHW
    Regulation Number
    884.3575
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOTEQUE AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bioteque's vaginal pessaries are indicated as removable devices placed in the vaginal cavity to provide a non-surgical alternative for the treatment of organ prolapse and to relieve the symptoms of pelvic relaxation with and without urinary incontinence.
    Device Description
    Not Found
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    K Number
    K003380
    Device Name
    BIOTEQUE VAGINAL DILATOR
    Manufacturer
    BIOTEQUE AMERICA, INC.
    Date Cleared
    2001-01-29

    (90 days)

    Product Code
    HDX
    Regulation Number
    884.3900
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOTEQUE AMERICA, INC.

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