TUBE-STAT— 510(k) K843490

Substantially Equivalent

Concept, Inc.

FDA 510(k) clearance K843490 for TUBE-STAT, Substantially Equivalent on 1984-10-04. Applicant: Concept, Inc..

Clearance details

Applicant: Concept, Inc.
Product code: Code BSR
Advisory panel: Anesthesiology
Date received: 1984-09-06
Decision date: 1984-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code BSR

product code BSR

Death: 2
Other: 1
Total: 3

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.