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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K240664

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) · SurGenTec, LLC · decided 2024-08-09 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
BMAC Diamond Needle SR07-1300Surgentec, LLCPDQ00810131881009
BMAN Solid Diamond Needle Pouched SR07-1002Surgentec, LLCPDQ00810131880934
BMAN Solid Diamond Needle AssemblySR07-1000Surgentec, LLCPDQ00810131880927
BMAC Diamond Needle Kit SR07-1301Surgentec, LLCPDQ00810131881016
Site Prep Barbed Guide +4 SR07-6022Surgentec, LLCPDQ00850040139457
BMAC Diamond Needle - Two Pack SR07-1302Surgentec, LLCPDQ00810131881023
BMAC Bevel Needle Kit SR07-1501Surgentec, LLCPDQ00810131881078
BMAC Diamond Needle Pouched SR07-1202Surgentec, LLCPDQ00810131880996
BMAC Bevel Needle Pouched SR07-1402Surgentec, LLCPDQ00810131881054
Bone Marrow Access Needle with Sheath - 25x Max SR07-1925Surgentec, LLCPDQ00810131881108
BMAC Bevel Needle Kit - Two Pack SR07-1503Surgentec, LLCPDQ00810131881092
BMAC Bevel Needle - Two Pack SR07-1502Surgentec, LLCPDQ00810131881085
BMAN Solid Diamond Needle Kit - Two Pack SR07-1103Surgentec, LLCPDQ00810131880972
BMAC Diamond Needle Kit - Two Pack Copy SR07-1303Surgentec, LLCPDQ00810131881030
BMAC Bevel Needle SR07-1500Surgentec, LLCPDQ00810131881061
Site Prep Locator - Row Series SR07-6010Surgentec, LLCPDQ00850040139402
Site Prep Barbed Guide +2 SR07-6021Surgentec, LLCPDQ00850040139440
BMAN Solid Diamond Needle SR07-1100Surgentec, LLCPDQ00810131880941
BMAN Solid Diamond Needle - Two Pack SR07-1102Surgentec, LLCPDQ00810131880965
BMAC Diamond Needle Assembly SR07-1200Surgentec, LLCPDQ00810131880989
BMAN Solid Diamond Needle Kit SR07-1101Surgentec, LLCPDQ00810131880958
BMAC Bevel Needle Assembly SR07-1400Surgentec, LLCPDQ00810131881047
Site Prep Barbed Guide SR07-6020Surgentec, LLCPDQ00850040139433