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510(k) Data Aggregation

    K Number
    K170203
    Device Name
    System, Applicator, Radionuclide, Remote Controlled
    Manufacturer
    Kobold, LLC
    Date Cleared
    2017-06-01

    (129 days)

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

    Kobold, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kobold Prostate HDR Template and Stepper Template are indicated for use as an accessory for high dose rate brachytherapy treatment of the prostate. The Stainless Steel Interstitial Needles and corresponding stylets are indicated for use as an accessory for high dose rate brachytherapy treatment of the prostate.
    Device Description
    The Kobold Prostate HDR Template and Stepper Template are accessories to be used where ultrasound-guided interstitial temporary high dose rate (HDR) brachytherapy treatment of the prostate is accepted by up-to-date clinical guidelines. The templates are ergonomically designed for freehand HDR technique. The templates are best used with biplanar transrectal ultrasound and confirmatory fluoroscopy. The templates are single-use, disposable devices shipped nonsterile. It is customizable for almost any prostate size or shape. The templates include four suture holes at the corners to secure the template to the perineum. The templates are available in various gauge sizes to match the most common needles sizes. These devices are for continuous use of up to 24 hours of contact with the patient. For workflows that require a stepper, the Kobold Prostate HDR Stepper Template fits into the Elekta Martinez Template Holder. The stainless steel needles are 17 gauge in either a pencil point tip or a bevel tip. The associated stylets are inserted into needles to stiffen the needles during implantation of the needles into the patient and to stiffen the needles between radiation therapy fractions. The Kobold Stainless Steel Interstitial Needles are intended for single use and are disposable. The maximum implantation time for these needles is less than 24 hours.
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    K Number
    K160610
    Device Name
    Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set
    Manufacturer
    KOBOLD, LLC
    Date Cleared
    2017-02-13

    (347 days)

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

    KOBOLD, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CT Compatible / MR Unsafe HDR Kobold® Fletcher-model Tandem and Ovoid Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus with a Fletcher type applicator is accepted by up-to-date clinical guidelines. The Kobold® Fletcher-model Tandem and Ovoid Applicator Set is intended for continuous use of up to 24 hours of contact with patient. The CT Compatible / MR Unsafe HDR Kobold® Henschke-model Tandem and Ovoid Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus with a Henschke type applicator is accepted by up-to-date clinical guidelines. The Kobold® Henschke-model Tandem and Ovoid Applicator Set is intended for continuous use of up to 24 hours of contact with patient. The CT Compatible / MR Unsafe HDR Kobold® Vaginal Cylinder Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the vagina is accepted by up-to-date clinical guidelines. The Kobold® Vaginal Cylinder Applicator Set is intended for continuous use of up to 24 hours of contact with patient. The CT Compatible / MR Unsafe HDR Kobold® Miami Cylinder Applicator Set is indicated for use in any patient case where high dose rate (HDR) radiation treatment of the cervix, vagina, and uterus with a Miami type applicator is acceptable by up-to-date clinical guidelines. The Kobold® Miami Cylinder Set is intended for continuous use of up to 24 hours of contact with patient.
    Device Description
    The CT Compatible / MR Unsafe HDR Kobold® Fletcher-model Tandem and Ovoid Applicator Set design is based on the conventional modified Fletcher GYN applicator. Kobold manufactures versions compatible with HDR afterloaders. This applicator is mainly utilized for HDR radiation boosts to the cervix and parametrial tissues in conjunction with external beam radiation therapy. This GYN set consists of precision manufactured intrauterine tandems and a pair of interlocking vaginal colpostats with Fletcher type unshielded barrel or cylinder ovoids (all components are designed to allow for customization of the treated geometry). The distance between the two lateral ovoids is adjustable with a lock knob. Four differing tandem geometries are provided in the set: one straight, one with slight curvature, one with medium curvature, and one with maximal curvature. These allow for maximal accommodation of the uterine shape and flexure. The CT Compatible / MR Unsafe HDR Kobold® Henschke-model Tandem and Ovoid Applicator Set design is based on the conventional modified Henschke GYN applicator. Kobold manufactures versions compatible with HDR afterloaders. This applicator is mainly utilized for HDR radiation boosts to the cervix and parametrial tissues in conjunction with external beam radiation therapy. This GYN set consists of precision manufactured intrauterine tandems and a pair of interlocking vaginal colpostats with Henschke type unshielded ovoids (all components are designed to allow for customization of the treated geometry). The distance between the ovoids is adjustable with a lock knob. Four differing tandem geometries are provided in the set: one straight, one with slight curvature, one with medium curvature, and one with maximal curvature. These allow for maximal accommodation of the uterine shape and flexure. The CT Compatible / MR Unsafe HDR Kobold® Vaginal Cylinder Applicator Set design is based on conventional cylindrical HDR delivery systems with a connector interface compatible with major manufacturers' afterloaders. 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 precision manufactured vaginal cylinders of varied diameters for optimal radiation treatment delivery and anatomical customization. The CT Compatible / MR Unsafe HDR Kobold® Miami Cylinder Applicator Set design is based on conventional modified Miami applicators with a connector interface compatible with major manufacturers' afterloaders. This applicator set 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. Various tandems are provided: straight. slight curvature. medium curvature, and maximal curvature. These allow for maximal accommodation of the uterine flexure.
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    K Number
    K142330
    Device Name
    Kobold Ring and Tandem Applicator Set
    Manufacturer
    KOBOLD, LLC
    Date Cleared
    2015-04-09

    (232 days)

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

    KOBOLD, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CT Compatible / MR Unsafe HDR Kobold Ring and Tandem Applicator Set 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 Kobold Ring and Tandem Applicator Set is intended for continuous use of up to 24 hours of contact with patient.
    Device Description
    The CT Compatible / MR Unsafe HDR Kobold Ring and Tandem Applicator Set™ design is based on the modified conventional Ring/Tandem 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 applicator consists of precision manufactured intrauterine rings, ring caps, and tandems, interlocking via a ring bracket. All components are designed for a defined geometry. The rings are provided in three different angles (30 degrees, 45 degrees, and 60 degrees) with three different tandem lengths (20 mm, and 60 mm from the ring axis) provided for each ring angle. Two ring caps are provided (5.0 mm and 7.0 mm).
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