FDA 510(k) Application Details - K251505

Device Classification Name	Cuff, Nerve   More FDA Info for this Device
510(K) Number	K251505
Device Name	Cuff, Nerve
Applicant	Alafair Biosciences 6101 W Courtyard Dr Ste 1-225 Austin, TX 78730 US Other 510(k) Applications for this Company
Contact	Sarah Mayes Other 510(k) Applications for this Contact
Regulation Number	882.5275   More FDA Info for this Regulation Number
Classification Product Code	JXI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/2025
Decision Date	07/22/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review