FDA 510(k) Application Details - K243525

Device Classification Name	Needle, Conduction, Anesthetic (W/Wo Introducer)   More FDA Info for this Device
510(K) Number	K243525
Device Name	Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant	PAJUNK GmbH Medizintechnologie Karl-Hall-Str. 1 Pajunkstr. 1 Geisingen 78187 DE Other 510(k) Applications for this Company
Contact	Christian Quass Other 510(k) Applications for this Contact
Regulation Number	868.5150   More FDA Info for this Regulation Number
Classification Product Code	BSP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/2024
Decision Date	03/24/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review