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510(k) Data Aggregation
K Number
K242073Device Name
STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)
Manufacturer
TSK Laboratory International Japan KK
Date Cleared
2024-10-23
(99 days)
Product Code
QYM
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
TSK Laboratory International Japan KK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended to inject into or aspirate from, the body. The device is intended for intravitreal use.
Device Description
The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a luer lock or luer slip piston syringe. The device can be used by health care professionals. The hub of the needle can be a standard size or a reduced size (low dead space) that is designed to reduce medication waste. The device is operated manually by attaching it to a piston syringe. Target injection sites include subcutaneous, intramuscular, intradermal, and intravitreal.
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K Number
K231734Device Name
STERiJECT Low Dead Space, STERiJECT The Invisible Needle
Manufacturer
TSK Laboratory International Japan KK
Date Cleared
2024-03-08
(268 days)
Product Code
QNS, ONS
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
TSK Laboratory International Japan KK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to inject into or aspirate from, the body.
Device Description
A low dead space single lumen hypodermic needle is a device designed to reduce medication waste. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a luer lock or luer slip piston syringes. The devices are intended to be used by doctors, medical- related practitioners and self-injection by patients as directed by doctors or medical-related practitioners. The needle hub or connector of the needle is designed to reduce medication waste. Low dead space needles are operated manually by attaching it to a piston syringe. Target injection sites include subcutaneous, intramuscular, intravascular, and intradermal.
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