FDA 510(k) Application Details - K230326

Device Classification Name	More FDA Info for this Device
510(K) Number	K230326
Device Name	ENFit to ENFit Extension Sets
Applicant	Vesco Medical 60 Collegeview Road, Suite 144 Westerville, OH 43081 US Other 510(k) Applications for this Company
Contact	Chris O'Keefe Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/06/2023
Decision Date	11/02/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review