FDA 510(k) Application Details - K172614

Device Classification Name	More FDA Info for this Device
510(K) Number	K172614
Device Name	Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medic
Applicant	Caldera Medical, Inc. 5171 Clareton Drive Agoura Hills, CA 91301 US Other 510(k) Applications for this Company
Contact	Vicki Gail Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/31/2017
Decision Date	05/04/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review