Pre-filled Syringe with Saline— 510(k) K220060

Substantially Equivalent

Jiangsu Caina Medical Co.,Ltd

FDA 510(k) clearance K220060 for Pre-filled Syringe with Saline, Substantially Equivalent on 2022-06-10. Applicant: Jiangsu Caina Medical Co.,Ltd.

Clearance details

Applicant: Jiangsu Caina Medical Co.,Ltd
Product code: Code NGT
Advisory panel: General Hospital
Date received: 2022-01-10
Decision date: 2022-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiangyin, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code NGT

product code NGT

Death: 12
Malfunction: 2,008
Other: 4
Total: 2,024

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.