DeviceClearance

AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE— 510(k) K111034

Substantially Equivalent

Am USA

FDA 510(k) clearance K111034 for AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE, Substantially Equivalent on 2011-07-14. Applicant: Am USA.

Clearance details

Applicant
Am USA
Product code
Code NGT
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Nashville, TN, US
Download summary PDFView 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, through . 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.