FDA 510(k) Application Details - K250213

Device Classification Name	Probe, Radiofrequency Lesion   More FDA Info for this Device
510(K) Number	K250213
Device Name	Probe, Radiofrequency Lesion
Applicant	Stryker Instruments 1941 Stryker Way Portage, MI 49002 US Other 510(k) Applications for this Company
Contact	Dayana Manganese Other 510(k) Applications for this Contact
Regulation Number	882.4725   More FDA Info for this Regulation Number
Classification Product Code	GXI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/24/2025
Decision Date	05/15/2025
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