510(k) K240664— ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
Substantially EquivalentSurGenTec, LLC
Clearance details
- Applicant
- SurGenTec, LLC
- Product code
- Code KNW
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boca Raton, FL, US
Adverse events under product code KNW
product code KNW- Death
- 9
- Injury
- 965
- Malfunction
- 10,444
- Other
- 3
- Total
- 11,421
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.