K243945 is an FDA 510(k) clearance for the ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit). This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by SurGenTec, LLC (Boca Raton, US). The FDA issued a Cleared decision on April 24, 2025, 125 days after receiving the submission on December 20, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K243945 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2024 |
| Decision Date | April 24, 2025 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KNW — Instrument, Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |