Praxiject 0.9% NaCl— 510(k) K192414

Substantially Equivalent

Medxl, Inc.

FDA 510(k) clearance K192414 for Praxiject 0.9% NaCl, Substantially Equivalent on 2020-02-13. Applicant: Medxl, Inc..

Clearance details

Applicant: Medxl, Inc.
Product code: Code NGT
Advisory panel: General Hospital
Date received: 2019-09-04
Decision date: 2020-02-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Pointe-Claire, CA

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.