510(k) K240297— Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS)
Substantially EquivalentUs Medical Innovations, LLC
Clearance details
- Applicant
- Us Medical Innovations, LLC
- Product code
- Code OAB
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tacoma Park, MD, US
Adverse events under product code OAB
product code OAB- Death
- 5
- Total
- 5
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.