PREVENT Kit— 510(k) K232379
Substantially EquivalentClear Choice Therapeutics
FDA 510(k) clearance K232379 for PREVENT Kit, Substantially Equivalent on 2024-02-05. Applicant: Clear Choice Therapeutics.
Clearance details
- Applicant
- Clear Choice Therapeutics
- Product code
- Code OMP
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raleigh, NC, US
Adverse events under product code OMP
product code OMP- Death
- 31
- Injury
- 1,707
- Malfunction
- 4,047
- Other
- 1
- Total
- 5,786
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.