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510(k) Data Aggregation
K Number
K222385Device Name
Bifurcated Needle
Manufacturer
Anhui Tiankang Medical Technology Co., Ltd.
Date Cleared
2022-12-06
(120 days)
Product Code
SCL, LDH
Regulation Number
880.5570Why 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
K182582Device 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
880.5570Why 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
K172062Device 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
880.5570Why 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
K162917Device Name
Allerhope Allergy Skin Tester
Manufacturer
PROCARE INDUSTRIAL CO., LIMITED
Date Cleared
2017-08-17
(303 days)
Product Code
SCL, LDH
Regulation Number
880.5570Why 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
K032528Device Name
BD ECLIPSE BIFURCATED NEEDLE
Manufacturer
BECTON DICKINSON & CO.
Date Cleared
2003-09-09
(25 days)
Product Code
SCL, LDH
Regulation Number
880.5570Why 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
K031630Device Name
BIFURCATED ALLERGY SKIN TESTING NEEDLE
Manufacturer
PRECISION MEDICAL PRODUCTS, INC.
Date Cleared
2003-08-07
(72 days)
Product Code
SCL, LDH
Regulation Number
880.5570Why 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
K020523Device Name
BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757
Manufacturer
BD
Date Cleared
2002-03-20
(29 days)
Product Code
SCL, LDH
Regulation Number
880.5570Why 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
K020500Device Name
UNIVEC BIFURCATED SLIDING SHEATH SYRINGE
Manufacturer
UNIVEC, INC.
Date Cleared
2002-03-19
(33 days)
Product Code
SCL, LDH
Regulation Number
880.5570Why 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
K012515Device Name
BIFURCATED VACCINATING NEEDLE
Manufacturer
PRECISION MEDICAL PRODUCTS, INC.
Date Cleared
2001-09-19
(44 days)
Product Code
SCL, LDH
Regulation Number
880.5570Why 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
K011979Device Name
ALLERSHARP ALLERGY SKIN TESTER
Manufacturer
HMB MEDICAL CONCEPTS, LTD.
Date Cleared
2001-09-14
(81 days)
Product Code
SCL, LDH
Regulation Number
880.5570Why 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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