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510(k) Data Aggregation
K Number
K231856Device Name
TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))
Manufacturer
MedExel Co., Ltd.
Date Cleared
2024-03-15
(266 days)
Product Code
QNQ
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
MedExel Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TopFine® LDS (Low Dead Space) Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.
Device Description
The TopFine® LDS (Low Dead Space) Syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a hypodermic single lumen needle which is a permanently attached. The device is used to inject fluids into, or withdraw fluids from, the body. It is made of plastic and silicone materials that allows for smooth plunger movement, and is manually operated. This is a single-use device. This product is packed by sterile paper and sterilized by Ethylene Oxide gas.
The proposed device has 2 models depending on the diameter of the needle.
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K Number
K152410Device Name
Top Fine Pen Needle
Manufacturer
MEDEXEL CO., LTD.
Date Cleared
2016-02-02
(160 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
MEDEXEL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Top Fine® Pen Needle is intended for use with pen injector device for the subcutaneous injection of insulin.
Device Description
Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm, 8mm, 12mm). Top Fine® Pen Needles are sterile (EO gas sterilization), non-toxic and non-pyrogenic.
Top Fine® Pen Needle assembly consists of hub, needle cap, sterile cap and sterile paper.
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