0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe— 510(k) K191378

Substantially Equivalent

Medline Industries, Inc.

FDA 510(k) clearance K191378 for 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe, Substantially Equivalent on 2019-09-15. Applicant: Medline Industries, Inc..

Clearance details

Applicant: Medline Industries, Inc.
Product code: Code NGT
Advisory panel: General Hospital
Date received: 2019-05-23
Decision date: 2019-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northfiled, IL, US

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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.