Disposable Automatically Retractable Safety Syringes (with detachable needle)— 510(k) K222452

Clearance details

Applicant

Shantou Wealy Medical Instrument Co.,Ltd

Product code

Code MEG

Device class

Class 2

Regulation

21 CFR 880.5860

Advisory panel

General Hospital

Date received

2022-08-15

Decision date

2022-11-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shantou, 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

• K210216 — Disposable Automatically Retractable Insulin Safety Syringe2022-03-04
• K203613 — ENFit Reusable Enteral Syringe2021-08-27
• K203410 — ENFit Disposable Enteral Syringe2021-06-28
• K141640 — AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE2014-11-19
• K113587 — AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE)2012-02-24

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 →