STERILE FIELD SALINE PRE-FILLED SYRINGE(S)— 510(k) K082837

Substantially Equivalent

Excelsior Medical Corp.

FDA 510(k) clearance K082837 for STERILE FIELD SALINE PRE-FILLED SYRINGE(S), Substantially Equivalent on 2008-12-18. Applicant: Excelsior Medical Corp..

Clearance details

Applicant: Excelsior Medical Corp.
Product code: Code NGT
Advisory panel: General Hospital
Date received: 2008-09-26
Decision date: 2008-12-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Neptune, NJ, 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.