SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311— 510(k) K101270

Substantially Equivalent

Excelsior Medical Corp.

FDA 510(k) clearance K101270 for SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311, Substantially Equivalent on 2011-02-10. Applicant: Excelsior Medical Corp..

Clearance details

Applicant: Excelsior Medical Corp.
Product code: Code NGT
Advisory panel: General Hospital
Date received: 2010-05-06
Decision date: 2011-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundas, On, CA

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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.