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510(k) Data Aggregation
K Number
K232950Device Name
Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle
Manufacturer
Date Cleared
2024-06-12
(266 days)
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Perfect Medical Industry (VN) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Sterile Disposable Syringe is intended to be used to withdraw solutions into patient's body. Sterile Disposable Syringe with needle are intended to be used with a luer slip or luer lock syringe to withdraw solutions and insert solutions into patient's body. Sterile Disposable Syringe with safety needle is intended to be used with a luer slip or luer lock syringe to withdraw solutions into patient's body. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
Device Description
The Sterile Disposable Syringe consists of barrel, plunger and piston. The proposed device is available in luer slip or luer lock connector types which are intended to be connected with a hypodermic needle. The Sterile Disposable Syringe with Needle is available in 18-19, 21-26 gauge and 3/8 – 2 inch lengths. The proposed device is also available with fixed needle 25-26 gauge and 1/2 – 1 inch length. The Sterile Disposable Syringe with Safety Needle is available in 18-19, 21-26 gauge and 3/8 – 2 inch lengths. The safety cap will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. All subject device are operated manually.
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