SILBRONCHO DOUBLE LUMEN TUBE— 510(k) K051522

Name: FDA 510(k) clearance K051522
Creator: U.S. Food and Drug Administration
Published: 2005-08-17

Substantially Equivalent

Fuji Systems Corp.

FDA 510(k) clearance K051522 for SILBRONCHO DOUBLE LUMEN TUBE, Substantially Equivalent on 2005-08-17. Applicant: Fuji Systems Corp.. Device class: 2.

Clearance details

Applicant: Fuji Systems Corp.
Product code: Code CBI
Device class: Class 2
Regulation: 21 CFR 868.5740
Advisory panel: Anesthesiology
Date received: 2005-06-08
Decision date: 2005-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mccordsville, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CBI

product code CBI

Death: 4
Malfunction: 594
Total: 598

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.