Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe— 510(k) K190183

Clearance details

Applicant

Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

Product code

Code MEG

Device class

Class 2

Regulation

21 CFR 880.5860

Advisory panel

General Hospital

Date received

2019-02-01

Decision date

2019-10-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Taihu, Anqing City, CN

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• K230287 — SaviSafe Safety Device2023-11-21
• K231165 — Shina Syringe; Shina Safety Syringe2023-10-27
• K231907 — Medline Safety Insulin and TB Syringes2023-10-18

• K234024 — HWJECT Auto-disable syringe2024-03-19
• K230061 — Insulin Syringe2023-11-30
• K230043 — Insulin Pen Needle2023-09-20
• K223323 — Blood Collection Needle (with/without Needle Holder)2023-03-24
• K222124 — Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle2022-11-04

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 →