CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES— 510(k) K100669
Substantially EquivalentUs Medical Innovations, LLC
FDA 510(k) clearance K100669 for CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES, Substantially Equivalent on 2011-04-06. Applicant: Us Medical Innovations, LLC.
Clearance details
- Applicant
- Us Medical Innovations, LLC
- Product code
- Code GEI
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.