Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact