ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (K243945)
Description
ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) by SurGenTec, LLC, an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243945
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (K243945) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240664 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC | 2024 |
| K190163 | ALARA Neuro Access Kit | SurGenTec, LLC | 2019 |
| K170539 | Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone... | Avitus Orthopaedics, Inc. | 2017 |
| K131157 | RANFAC BONE MARROW ASPIRATION NEEDLE | Ranfac, Corp. | 2013 |
Trace the full predicate network for K243945
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.