ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
FDA 510(k) K240664 · SurGenTec, LLC
510(k) numberK240664
Submission
- Device name
- ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
- Applicant
- SurGenTec, LLC
Boca Raton, FL, US - Received
- March 8, 2024
- Decision date
- August 9, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNW – Instrument, Biopsy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) cleared by the FDA?
ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (K240664) received a 510(k) decision of Substantially Equivalent on August 9, 2024, 154 days after the submission was received.
What is the product code of K240664?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.