FDA 510(k) Application Details - K202433

Device Classification Name	More FDA Info for this Device
510(K) Number	K202433
Device Name	Aqueduct 200 Cervical Dilation Balloon Catheter
Applicant	GTIMD LLC 6 Columbia Drive Amherst, NH 03031 US Other 510(k) Applications for this Company
Contact	Eran Levit Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PON Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2020
Decision Date	10/15/2021
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