evoDrill Cranial Perforator— 510(k) K231403
Substantially EquivalentEvonos GmbH & Co. KG
FDA 510(k) clearance K231403 for evoDrill Cranial Perforator, Substantially Equivalent on 2024-03-06. Applicant: Evonos GmbH & Co. KG.
Clearance details
- Applicant
- Evonos GmbH & Co. KG
- Product code
- Code HBF
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tuttingen, DE
Adverse events under product code HBF
product code HBF- Injury
- 587
- Malfunction
- 621
- Other
- 1
- Total
- 1,209
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.