FDA 510(k) Application Details - K242002

Device Classification Name	Cannula, Manipulator/Injector, Uterine   More FDA Info for this Device
510(K) Number	K242002
Device Name	Cannula, Manipulator/Injector, Uterine
Applicant	Femasys Inc. 3950 Johns Creek Ct. Suite 100 Suwanee, GA 30024 US Other 510(k) Applications for this Company
Contact	Carrie Engleman Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LKF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/09/2024
Decision Date	11/22/2024
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