FDA 510(k) Application Details - K241917

Device Classification Name	Stimulator, Nerve   More FDA Info for this Device
510(K) Number	K241917
Device Name	Stimulator, Nerve
Applicant	Retropsoas Technologies, LLC 34 Countryside Lane Frontenac, MO 63131 US Other 510(k) Applications for this Company
Contact	Nicholas Poulos Other 510(k) Applications for this Contact
Regulation Number	874.1820   More FDA Info for this Regulation Number
Classification Product Code	ETN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2024
Decision Date	07/31/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review