AMSafe Pre-Filled Normal Saline Flush Syringe— 510(k) K213522

Substantially Equivalent

Amsino International, Inc.

FDA 510(k) clearance K213522 for AMSafe Pre-Filled Normal Saline Flush Syringe, Substantially Equivalent on 2022-03-22. Applicant: Amsino International, Inc..

Clearance details

Applicant: Amsino International, Inc.
Product code: Code NGT
Advisory panel: General Hospital
Date received: 2021-11-03
Decision date: 2022-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pomona, CA, US

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.