FDA 510(k) Application Details - K241367

Device Classification Name	Probe, Radiofrequency Lesion   More FDA Info for this Device
510(K) Number	K241367
Device Name	Probe, Radiofrequency Lesion
Applicant	Shanghai SAMedical & Plastic Instruments Co., Ltd. Level 1-4 & Room 501,506,510, Building No.12, No.2755 Sanlu Highway, Minhang District Shanghai 201100 CN Other 510(k) Applications for this Company
Contact	Louis Li 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	05/14/2024
Decision Date	01/23/2025
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