CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM— 510(k) K090864
Substantially EquivalentIntegra Radionics, Inc.
FDA 510(k) clearance K090864 for CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM, Substantially Equivalent on 2009-05-08. Applicant: Integra Radionics, Inc..
Clearance details
- Applicant
- Integra Radionics, Inc.
- Product code
- Code LFL
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burlington, MA, US
Adverse events under product code LFL
product code LFL- Death
- 29
- Injury
- 1,046
- Malfunction
- 21,642
- Total
- 22,717
Source: openFDA MAUDE database, through . 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.