RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE— 510(k) K051947
Substantially EquivalentRadionics, A Division of Tyco Healthcare Group LP
FDA 510(k) clearance K051947 for RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE, Substantially Equivalent on 2005-08-22. Applicant: Radionics, A Division of Tyco Healthcare Group LP.
Clearance details
- Applicant
- Radionics, A Division of Tyco Healthcare Group LP
- 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.