FDA 510(k) Application Details - K231691

Device Classification Name	Electrode, Needle   More FDA Info for this Device
510(K) Number	K231691
Device Name	Electrode, Needle
Applicant	TeDan Surgical Innovations Inc. 12320 Cardinal Meadow Dr. Suite 150 Sugar Land, TX 77478 US Other 510(k) Applications for this Company
Contact	Lynne Davies Other 510(k) Applications for this Contact
Regulation Number	882.1350   More FDA Info for this Regulation Number
Classification Product Code	GXZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/09/2023
Decision Date	06/29/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review