Sonicision Cordless Ultrasonic Dissection Device— 510(k) K153371
Substantially EquivalentCovidien, LLC
FDA 510(k) clearance K153371 for Sonicision Cordless Ultrasonic Dissection Device, Substantially Equivalent on 2016-03-28. Applicant: Covidien, LLC. Device class: Unclassified.
Clearance details
- Applicant
- Covidien, LLC
- Product code
- Product code LFL
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boulder, CO, US
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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.