Nustat XR— 510(k) K160578

Name: FDA 510(k) clearance K160578
Creator: U.S. Food and Drug Administration
Published: 2016-06-29

Substantially Equivalent

Beeken Biomedical, LLC

FDA 510(k) clearance K160578 for Nustat XR, Substantially Equivalent on 2016-06-29. Applicant: Beeken Biomedical, LLC. Device class: Unclassified.

Clearance details

Applicant: Beeken Biomedical, LLC
Product code: Code QSY
Device class: Unclassified
Advisory panel: Unknown
Date received: 2016-03-01
Decision date: 2016-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stoughton, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code QSY

product code QSY

Death: 5
Other: 1
Total: 6

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.