FDA 510(k) Application Details - K212328

Device Classification Name	Needle, Conduction, Anesthetic (W/Wo Introducer)   More FDA Info for this Device
510(K) Number	K212328
Device Name	Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant	DiscCath LLC 62 E 88th Street New York, NY 10128 US Other 510(k) Applications for this Company
Contact	Gregory E. Lutz 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	07/27/2021
Decision Date	09/26/2021
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