Retractable Safety Insulin Syringe— 510(k) K193022

Clearance details

Applicant

Jiangsu Caina Medical Co.,Ltd

Product code

Code MEG

Device class

Class 2

Regulation

21 CFR 880.5860

Advisory panel

General Hospital

Date received

2019-10-30

Decision date

2020-07-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Jiangyin, CN

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• K221406 — Vented Vial Transfer Pin2022-10-28

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 →