# K211484: Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles

- Pathway: 510(k) (Traditional)
- Applicant: Shinva Ande Healthcare Apparatus Co., Ltd.
- Decided: Mar 1, 2022 after 293 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Disposable Sterile Syringe with Safety Needle The disposable 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. Disposable Sterile Syringe with Needle The disposable sterile syringe with needle is intended for use the aspiration and injection of fluids for medical purpose. Disposable Sterile Syringe The disposable 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. Disposable Safety Needles The disposable 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.

Source page: https://510kreport.com/device/K211484
Methodology: https://510kreport.com/methodology