ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)— 510(k) K243945
Substantially EquivalentSurGenTec, LLC
FDA 510(k) clearance K243945 for ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit), Substantially Equivalent on 2025-04-24. Applicant: SurGenTec, 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.