K243945
- 510(k) number
- K243945
- Device name
- ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
- Applicant
- SurGenTec, LLC FL · US
- Product code
- KNW — Instrument, Biopsy
- Decision date
- 2025-04-24
- Date received
- 2024-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243945.pdf
Official FDA record: K243945
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.