ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)— 510(k) K243945

Name: FDA 510(k) clearance K243945
Creator: U.S. Food and Drug Administration
Published: 2025-04-24

Substantially Equivalent

SurGenTec, 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. Device class: 2.

Clearance details

Applicant: SurGenTec, LLC
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 2024-12-20
Decision date: 2025-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

Download summary PDF View on FDA.gov ↗

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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, 2020-01-01 through 2026-04-23. 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.