FDA 510(k) Application Details - K240595

Device Classification Name	Brush, Endometrial   More FDA Info for this Device
510(K) Number	K240595
Device Name	Brush, Endometrial
Applicant	Utepreva LLC 100 Jericho Quadrangle Suite 333 Jericho, NY 11753 US Other 510(k) Applications for this Company
Contact	Zanetta Malanowska-Stega Other 510(k) Applications for this Contact
Regulation Number	884.1100   More FDA Info for this Regulation Number
Classification Product Code	HFE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/2024
Decision Date	08/14/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review