CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V— 510(k) K082038

Substantially Equivalent

Clarus Medical, LLC

FDA 510(k) clearance K082038 for CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V, Substantially Equivalent on 2009-04-28. Applicant: Clarus Medical, LLC.

Clearance details

Applicant: Clarus Medical, LLC
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 2008-07-17
Decision date: 2009-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden Valley, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTR

product code BTR

Death: 92
Injury: 1,263
Malfunction: 7,475
Other: 2
Total: 8,832

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.