# K183665: Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Micsafe Medical Technology Co., Ltd.
- Decided: Sep 6, 2019 after 253 days
- Product code: MEG (Syringe, Antistick)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K771205 (1977). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170651: Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle, Yangzhou Medline Industry, Co., Ltd. (2017) Summary page 4.

## Indications for use
Safety Needles The safety needles are intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. 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. Sterile Syringe The sterile syringe is a sterile luer lock or luer slip syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose. Sterile Syringe with Safety Needle The sterile syringe with safety needle is intended for use in the aspiration and injection of fluids for medical purpose. 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 needle sticks. Sterile Syringe with Needle The sterile syringe with needle is intended for use the aspiration and injection of fluids for medical purpose. Hypodermic Needles for Single Use The hypodermic needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose.

Source page: https://510kreport.com/device/K183665
Methodology: https://510kreport.com/methodology