AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE— 510(k) K113555

Substantially Equivalent

Am USA

FDA 510(k) clearance K113555 for AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE, Substantially Equivalent on 2012-01-30. Applicant: Am USA.

Clearance details

Applicant: Am USA
Product code: Code NGT
Advisory panel: General Hospital
Date received: 2011-12-01
Decision date: 2012-01-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Nashville, TN, 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.