FirstFit Surgical Kit— 510(k) K240763
Substantially EquivalentFreudenberg Medical, LLC
FDA 510(k) clearance K240763 for FirstFit Surgical Kit, Substantially Equivalent on 2024-12-18. Applicant: Freudenberg Medical, LLC.
Clearance details
- Applicant
- Freudenberg Medical, LLC
- Product code
- Code EWL
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carpinteria, CA, US
Adverse events under product code EWL
product code EWL- Death
- 2
- Total
- 2
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.