Disposable Sterile Syringe with Safety Needle +3 more— 510(k) K211484

Clearance details

Device name as filed

Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles

Applicant

Shinva Ande Healthcare Apparatus Co., Ltd.

Product code

Code MEG

Device class

Class 2

Regulation

21 CFR 880.5860

Advisory panel

General Hospital

Date received

2021-05-12

Decision date

2022-03-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Zibo, CN

• K252098 — PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)2026-02-18
• K250847 — VaporShield2025-12-12
• K230287 — SaviSafe Safety Device2023-11-21
• K231165 — Shina Syringe; Shina Safety Syringe2023-10-27
• K231907 — Medline Safety Insulin and TB Syringes2023-10-18

• K201460 — Closed System Transfer Device2022-11-23
• K220057 — Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization2022-10-07
• K202060 — Disposable IV catheter2021-07-23
• K193657 — Disposable Enteral Feeding Syringe with Enfit Connector2020-09-12
• K162601 — Infusion Set for Single Use2017-05-31

Malfunction

1,373

Other

1

Total

1,374

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →