FDA 510(k) Application Details - K233710

Device Classification Name	More FDA Info for this Device
510(K) Number	K233710
Device Name	Symphion Operative Hysteroscopy System
Applicant	Minerva Surgical, Inc. 4255 Burton Drive Santa Clara, CA 95054 US Other 510(k) Applications for this Company
Contact	Michelle Becker Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/2023
Decision Date	01/17/2024
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