Cautery Protective Actuation System (CPAS)— 510(k) K232407
Substantially EquivalentSafer Surgeries Medical Devices, LLC
FDA 510(k) clearance K232407 for Cautery Protective Actuation System (CPAS), Substantially Equivalent on 2023-10-06. Applicant: Safer Surgeries Medical Devices, LLC.
Clearance details
- Applicant
- Safer Surgeries Medical Devices, LLC
- Product code
- Code GEI
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Duluth, GA, 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.