Search Results
Found 1 results
510(k) Data Aggregation
K Number
K143497Device Name
Safety Auto-Disable Syrine with Needle (Auto-Lock)
Manufacturer
GUANGDONG INTMED MEDICAL APPLIANCE CO., LTD
Date Cleared
2015-11-04
(330 days)
Product Code
MEG, FMF, FMI
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
GUANGDONG INTMED MEDICAL APPLIANCE CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Safety Auto-Disable Syringe with Needle (Auto-Lock) is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy.
It has a detachable needle with a dedicated fitting. The Safety Auto-Disable Syringe with Needle (Auto-Lock) contains an inner mechanism used to allow the needle to be retracted inside the plunger rod of the syringe after the operator's thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
Device Description
The proposed device is a single use, sterile syringe composed of barrel, plunger, plunger, push-button, spring, spring holder, rubber stopper, needle cap, and autodisable part.
Ask a Question
Page 1 of 1