NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET— 510(k) K063477

Substantially Equivalent

Novamed, LLC

FDA 510(k) clearance K063477 for NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET, Substantially Equivalent on 2007-02-09. Applicant: Novamed, LLC.

Clearance details

Applicant: Novamed, LLC
Product code: Code CCW
Advisory panel: Anesthesiology
Date received: 2006-11-16
Decision date: 2007-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

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Adverse events under product code CCW

product code CCW

Death: 31
Injury: 136
Malfunction: 3,703
Other: 1
Total: 3,871

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.