FDA 510(k) Application Details - K223866

Device Classification Name	Tenaculum, Uterine   More FDA Info for this Device
510(K) Number	K223866
Device Name	Tenaculum, Uterine
Applicant	Aspivix SA Chemin du Closel, 5 Renens 1020 CH Other 510(k) Applications for this Company
Contact	Mauro Rinaldi Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	HDC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2022
Decision Date	01/25/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review