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510(k) Data Aggregation

    K Number
    K130757
    Device Name
    KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET; KOBOLD LUER TRANSFER GUIDE TUBE SET
    Manufacturer
    SPENCER FILLMORE
    Date Cleared
    2014-04-03

    (379 days)

    Product Code
    JAQ
    Regulation Number
    892.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPENCER FILLMORE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Secure Lock transfer guide tubes have been developed to enable the connection of Varian's VariSource iX and 200 afterloaders and other third party applicators. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient's turnor site. Transfer guide tubes are non-myasive products that have no direct patient contact. The Luer transfer guide tubes have been developed to enable the connection of Varian's VariSource iX and 200 afterloaders and other third party applicators that include a Luer style connection. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient's tunnor site. Transfer guide tubes are non-invasive products that have no direct patient contact. The Luer interstitial extenders have been developed to enable the connection of Luer transfer guide tube to Kobold Interstitial Needles. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient's tumor site. Interstitial extenders are non-invasive products that have no direct patient contact.
    Device Description
    i) Kobold Secure Lock Transfer Guide Tube Set™ Each tube is numbered to ensure correct connection of the applicator channel with the corresponding afterloader channel. Only a physician who has been trained in the appropriate afterloader systems should use the Secure Lock transfer guide tubes. These transfer guide tubes are compatible with VariSource iX and VariSource 200 afterloaders. ii) Kobold Interstitial Extender Set™ Each extender is numbered to ensure correct connection of the interstitial extenders and corresponding (1) transfer guide tube and (2) interstitial needle. Only a physician who has been trained in the appropriate afterloader systems should use the interstitial extenders.
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    K Number
    K123912
    Device Name
    KOBOLD FLETCHER TYPE APPLICATOR SET, KOBOLD HENSCHKE TYPE APPLICATOR SET
    Manufacturer
    SPENCER FILLMORE
    Date Cleared
    2013-05-14

    (146 days)

    Product Code
    JAQ
    Regulation Number
    892.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPENCER FILLMORE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CT/MRI Compatible HDR Fletcher Type Applicator is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus is accepted by up-to-date clinical guidelines. The CT/MRI Compatible HDR Henschke Type Applicator is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus is accepted by up-to-date clinical guidelines.
    Device Description
    1. The CT/MRI Compatible HDR Fletcher Type Applicator Set™ design is based on the conventional modified Fletcher GYN applicator with a click fit connector interface. This applicator is particularly useful in providing an HDR radiation boost to the cervix and parametrical tissues in conjunction with external beam radiation therapy. The set consists of precision manufactured intrauterine tandems and a pair of interlocking colpostats with Fletcher type unshielded ovoids ranging in size from 1cm to 3cm. All components are designed to allow for customization of the treated geometry. The distance between the ovoids is adjustable with a lock knob. Four different tandems are provided: one straight, one with a slight curvature of 15 degrees, one with medium curvature of 30 degrees, and one with a maximal curvature of 45 degrees. 2. The CT/MRI Compatible HDR Henschke Type Applicator Set™ design is based on the conventional modified Henschke GYN applicator with a click fit connector interface. This applicator is particularly useful in providing an HDR radiation boost to the cervix and parametrical tissues in conjunction with external beam radiation therapy. The set consists of precision manufactured intrauterine tandems and a pair of interlocking colpostats with Henschke type unshielded ovoids ranging in size from 2cm to 3cm. All components are designed to allow for customization of the treated geometry. The distance between the ovoids is adjustable with a lock knob. Four different tandems are provided: one straight, one with a slight curvature of 15 degrees, one with medium curvature of 30 degrees, and one with a maximal curvature of 45 degrees.
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    K Number
    K123941
    Device Name
    KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET
    Manufacturer
    SPENCER FILLMORE
    Date Cleared
    2013-04-30

    (131 days)

    Product Code
    JAQ
    Regulation Number
    892.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPENCER FILLMORE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CT/MRI Compatible Sure-guide Vaginal Cylinder Set is indicated for use in any patient case where High Dose Rate (HDR) radiation treatment of the vagina is acceptable by up-to-date clinical and practice guidelines. The CT/MRI Compatible Sure-guide Stump Vaginal Cylinder Set is indicated for use in any patient case where High Dose Rate (HDR) radiation treatment of the vagina is acceptable by up-to-date clinical and practice guidelines. The CT/MRI Compatible Miami HDR Set is indicated for use in any patient case where High Dose Rate (HDR) radiation treatment of the cervix, vagina, and uterus is acceptable by up-to-date clinical and practice guidelines.
    Device Description
    1. Vaginal The CT/MRI compatible Sure-guide Vaginal Cylinder Set design is based on conventional cylindrical HDR delivery systems with a click fit connector interface. This applicator is particularly useful in providing an HDR radiation as definitive treatment, adjuvant treatment, or as a treatment boost to the vaginal walls with or without external beam radiation therapy. The set consists of a precision manufactured Sure-guide cylinders of varied diameters for optimal radiation treatment delivery and anatomical customization. 2. Stump The CT/MRI Compatible Sure-guide Stump Vaginal Cylinder Set design is based on conventional cylindrical HDR delivery systems with a click fit connector interface. This applicator is particularly useful in providing an HDR radiation as definitive treatment, adjuvant treatment, or as a treatment boost to the vaginal walls with or without external beam radiation therapy. The set consists of a precision-manufactured Sure-guide Stump Cylinders of varied diameters for optimal radiation treatment delivery and anatomical customization. 3. Miami The CT/MRI Compatible Sure-guide Miami HDR applicator Set is designed according to the conventional modified Miami applicator with a click fit connector interface. This applicator is particularly useful when the vaginal vault space is limited or narrow due to tumor, restricted anatomy, or fibrosis. It can also be useful to treat tumors that extend from the uterus or cervix down onto the vaginal wall. The set consists of a precision manufactured intrauterine tandems and a full set of variable diameter Miami cylinders (all components are designed to allow for customization of the treated geometry). The distance that the tandem is inserted can be customized for each case. Four differing tandems are provided: one straight, one slight curvature, one medium curvature, and one maximal curvature. These allow for maximal accommodation of the uterine flexure.
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