Search Results
Found 1 results
510(k) Data Aggregation
K Number
K212518Device Name
Jeesung Safety Syringe and Single Use Needles
Manufacturer
Date Cleared
2022-08-18
(373 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
JeeSung Medical Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Jeesung safety syringe and single use needles is a sterile, single-use, disposable and non-reusable, manual retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
Device Description
Jeesung Safety Syringe and Single Use Needles is an integrated needle and piston syringe with an anti-needle-stick mechanism. There is a swell on the top of inside barrel, which can be used to fix the top of inside barrel. Four legs on the bottom of hub are caught on the top of inside barrel when the hub is pulled. After using this syringe (such as injecting medicine into body etc.), the hub of needle is pulled back to the inside of the barrel. Because the four legs of hub is bound to the top of the plunger which has a smaller swell part than the top of inside barrel for being caught. Therefore, by pushing plunger until it makes a binding sound, the hub can follow with the plunger. Then the plunger is broken off and the needle cannot be come out of the barrel. This renders the needle unusable and safe from accidental needle sticks.
Ask a Question
Ask a specific question about this device
Page 1 of 1