FDA 510(k) Application Details - K243889

Device Classification Name	Cuff, Nerve   More FDA Info for this Device
510(K) Number	K243889
Device Name	Cuff, Nerve
Applicant	Orthocell Ltd. Building 191, Murdoch University, South Street Murdoch 6150 AU Other 510(k) Applications for this Company
Contact	Kelly Hunter 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	12/18/2024
Decision Date	04/02/2025
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