Pre-Filled Normal Saline Flush Syringe— 510(k) K223584

Substantially Equivalent

Anhui Tianyang Pharmaceutical Co., Ltd.

FDA 510(k) clearance K223584 for Pre-Filled Normal Saline Flush Syringe, Substantially Equivalent on 2023-08-12. Applicant: Anhui Tianyang Pharmaceutical Co., Ltd..

Clearance details

Applicant: Anhui Tianyang Pharmaceutical Co., Ltd.
Product code: Code NGT
Advisory panel: General Hospital
Date received: 2022-12-01
Decision date: 2023-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tianchang, 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.