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510(k) Data Aggregation

    K Number
    K222385
    Device Name
    Bifurcated Needle
    Manufacturer
    Anhui Tiankang Medical Technology Co., Ltd.
    Date Cleared
    2022-12-06

    (120 days)

    Product Code
    SCL, LDH
    Regulation Number
    880.5570
    Why did this record match?
    Product Code :

    SCL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bifurcated Needle is intended for use in administering vaccines by the scarification method or administering epidermal allergens.
    Device Description
    The proposed Bifurcated Needle have two prongs. A small drop of smallpox vaccine was placed between the prongs and approximately fifteen punctures would be made into the skin. The needles were sterilized by EO to achieve a SAL of 10-6 and supplied sterile in packaging with a shelf life of five years.
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    K Number
    K182582
    Device Name
    Oryum and Ovem Epidermal Deri Prick Test Applicator
    Manufacturer
    Allergy & Applicator Depot, LLC
    Date Cleared
    2019-04-10

    (203 days)

    Product Code
    SCL, LDH
    Regulation Number
    880.5570
    Why did this record match?
    Product Code :

    SCL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Oryum and Ovem Epidermal Skin Prick Test Applicator is used for the percutaneous administration of diagnostic allergenic extracts.
    Device Description
    Oryum and Ovem Epidermal Skin Prick Test Applicator is a sterile, disposable, multiple test head applicator used to administer skin test substances to the surface of the skin. The Oryum and Ovem Epidermal Skin Prick Test Applicator are used for the conventional percutaneous application of substance directly onto the surface of the skin of diagnostic allergen extracts for performing skin tests for hypersensitivity reactions in individuals suspected of having allergies. The Oryum and Ovem Epidermal Skin Prick Test Applicator is offered in several configurations with 1 to 12 test heads arranged in an asymmetrical design. Each of the test heads have a "leg." At the tip of each leg is an array of protruding test points (tines). The tines utilize capillary action to hold the allergenic material for percutaneous delivery when the applicator is applied to the skin. This is an industry wide standard design. The test heads are designed to fit into the matching asymmetrical well design of a dipwell tray. The applicator loads the allergen from each well in the tray on to each test head. When properly applied to the skin, the applicator will leave visible indentations in the patient's skin corresponding to the test heads of each applicator is not intended to pierce the skin.
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    K Number
    K172062
    Device Name
    AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray
    Manufacturer
    MedScience Science Research Group, Inc.
    Date Cleared
    2018-03-05

    (241 days)

    Product Code
    SCL, LDH
    Regulation Number
    880.5570
    Why did this record match?
    Product Code :

    SCL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The skin test applicator is used for conventional administration (percutaneous application of allergenic extracts directly onto the surface of the skin) of diagnostic allergen extracts for performing allergy skin tests on the typical sites (the back and the volar surfaces of the forearms) for hypersensitivity reactions in individuals suspected of having allergies. The test tray is intended to hold allergenic extracts in a convenient arrangement for storage and use by the clinician.
    Device Description
    The AllergiEnd allergy skin testing products are supplied sterile and consist of two (2) devices: - Test Applicator - Test Tray The MedScience AllergiEnd Applicator and Tray are used together for the conventional percutaneous application of substance directly onto the surface of the skin of diagnostic allergen extracts for performing skin tests for hypersensitivity reactions in individuals suspected of having allergies. The AllergiEnd ST-9 Applicator has nine (9) test heads arranged in an asymmetrical design two (2) rows of four (4) test heads and a distal ninth test head. The test heads are labeled 1 through 9. Each of the 9 test heads has a "leg." At the tip of each leg is an array of nine (9) protruding test points (tines). The tines utilize capillary action to hold the allergenic material for percutaneous delivery when the applicator is applied to the skin. The test heads are designed to fit into the matching asymmetrical well design of the AllergiEnd ST-9 Test Tray. The applicator loads the allergen from each well in the tray on to each test head. The wells are numbered 1 to 9 to match the numbering on the applicator. When properly applied to the skin, the applicator will leave visible indentations in the patient's skin corresponding to the 9 test heads of each applicator is not intended to pierce the skin. The asymmetric design of the wells allows for only one possible orientation for the applicator to be placed in the tray. It is believed that the asymmetric design may help reduce the potential for operator error inherent in a symmetrical design and may also help the clinician avoid misreading of the skin reactions to the applied allergens. The tray is configured to hold either 36 or 72 test allergens in individual wells. The groups of wells, either 4 groups for 36 test wells or 8 groups for 72 test wells, determine the tray configuration. The clinician's testing preferences will determine which tray configuration to consider. The AllergiEnd ST-9 Multiple Well Test Tray is intended to hold small quantities of allergenic extracts in a convenient arrangement for storage and use. The Test Tray is not preloaded with allergens. The allergens are separately sourced and loaded by the clinician. Regardless of the number of wells, the test tray does not come in direct contact with the patient. The individual wells are numbered with an easily readable alpha-numeric system to facilitate recording reactions to specific allergens. By including an alpha-numeric numbering system in the AllergiEnd ST-9 Multiple Well Test Tray the test administrator has a clear organizational structure for locating each allergen and tracking the patient's response and for correctly documenting in the patient's medical records. The AllergiEnd ST-9 Multiple Well Test Tray also includes a locking lid that engages with a flexible seal. The locking/sealing cover protects the physician-filled allergenic material from contamination and evaporation. Additionally, the locking feature provides for secure handling. The locking feature does not affect the medical procedure, nor does it have any direct interaction with any of the allergenic extracts.
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    K Number
    K162917
    Device Name
    Allerhope Allergy Skin Tester
    Manufacturer
    PROCARE INDUSTRIAL CO., LIMITED
    Date Cleared
    2017-08-17

    (303 days)

    Product Code
    SCL, LDH
    Regulation Number
    880.5570
    Why did this record match?
    Product Code :

    SCL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Allerhope® Allergy Skin Tester is for the percutaneous administration of diagnostic allergenic extracts.
    Device Description
    Allerhope Allergy skin tester is a sterile, disposable, multiple test head applicator used to administer skin test substances. When used to apply allergenic extracts it provides a quick, convenient, and standardized procedure.
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    K Number
    K032528
    Device Name
    BD ECLIPSE BIFURCATED NEEDLE
    Manufacturer
    BECTON DICKINSON & CO.
    Date Cleared
    2003-09-09

    (25 days)

    Product Code
    SCL, LDH
    Regulation Number
    880.5570
    Why did this record match?
    Product Code :

    SCL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BD Eclipse™ Bifurcated Needle is intended for use in administering vaccines by the scarification method or administering epidermal allergens. The BD Eclipse™ Bifurcated Needle contains a mechanism that covers the needle point after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle.
    Device Description
    Not Found
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    K Number
    K031630
    Device Name
    BIFURCATED ALLERGY SKIN TESTING NEEDLE
    Manufacturer
    PRECISION MEDICAL PRODUCTS, INC.
    Date Cleared
    2003-08-07

    (72 days)

    Product Code
    SCL, LDH
    Regulation Number
    880.5570
    Why did this record match?
    Product Code :

    SCL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The bifurcated allergy skin testing needle is indicated for in-vivo diagnostic skin testing using the puncture technique.
    Device Description
    Not Found
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    K Number
    K020523
    Device Name
    BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757
    Manufacturer
    BD
    Date Cleared
    2002-03-20

    (29 days)

    Product Code
    SCL, LDH
    Regulation Number
    880.5570
    Why did this record match?
    Product Code :

    SCL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BD Bifurcated needle is intended for use in administering vaccines by the scarification method or administering epidermal allergens.
    Device Description
    The BD Bifurcated Needle will be offered in the following reorder numbers: 301754; 301755; 301756; 301757.
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    K Number
    K020500
    Device Name
    UNIVEC BIFURCATED SLIDING SHEATH SYRINGE
    Manufacturer
    UNIVEC, INC.
    Date Cleared
    2002-03-19

    (33 days)

    Product Code
    SCL, LDH
    Regulation Number
    880.5570
    Why did this record match?
    Product Code :

    SCL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Univec Bifurcated Sliding Sheath Syringe is a safety version of a bifurcated needle attached to a syringe barrel with the Univec Sliding Sheath Syringe mechanism. The Univec Sliding Sheath mechanism is used to aid in the prevention of needle stick injuries. This device is used in the same manner as a standard Bifurcated Needle to deliver vaccine or allergen to the patient.
    Device Description
    The Univec Bifurcated Sliding Sheath Syringe is a safety version of a bifurcated needle attached to a syringe barrel with the Univec Sliding Sheath Syringe mechanism.
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    K Number
    K012515
    Device Name
    BIFURCATED VACCINATING NEEDLE
    Manufacturer
    PRECISION MEDICAL PRODUCTS, INC.
    Date Cleared
    2001-09-19

    (44 days)

    Product Code
    SCL, LDH
    Regulation Number
    880.5570
    Why did this record match?
    Product Code :

    SCL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The bifurcated vaccinating needle is indicated for use in administering vaccine by the scarification method.
    Device Description
    Bifurcated Vaccinating Needle
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    K Number
    K011979
    Device Name
    ALLERSHARP ALLERGY SKIN TESTER
    Manufacturer
    HMB MEDICAL CONCEPTS, LTD.
    Date Cleared
    2001-09-14

    (81 days)

    Product Code
    SCL, LDH
    Regulation Number
    880.5570
    Why did this record match?
    Product Code :

    SCL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device system is used for prick application of allergen extracts in the performance of skin testing.
    Device Description
    Not Found
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