FDA 510(k) Application Details - K250380

Device Classification Name	Drills, Burrs, Trephines & Accessories (Simple, Powered)   More FDA Info for this Device
510(K) Number	K250380
Device Name	Drills, Burrs, Trephines & Accessories (Simple, Powered)
Applicant	Surgify Medical Oy Otakaari 5 Espoo 02150 FI Other 510(k) Applications for this Company
Contact	Jukka Kreander Other 510(k) Applications for this Contact
Regulation Number	882.4310   More FDA Info for this Regulation Number
Classification Product Code	HBE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/11/2025
Decision Date	03/13/2025
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