Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization— 510(k) K220057

Substantially Equivalent

Shinva Ande Healthcare Apparatus Co., Ltd.

FDA 510(k) clearance K220057 for Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization, Substantially Equivalent on 2022-10-07. Applicant: Shinva Ande Healthcare Apparatus Co., Ltd..

Clearance details

Applicant: Shinva Ande Healthcare Apparatus Co., Ltd.
Product code: Code MEG
Advisory panel: General Hospital
Date received: 2022-01-06
Decision date: 2022-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zibo, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code MEG

product code MEG

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.