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510(k) K202427

Device
Aqueduct 100 Plus Cervical Dilation Balloon Catheter
Applicant
GTIMD LLC
510(k) number
K202427
Product code
PON  
Decision
Substantially Equivalent (SESE)
Decision date
2020-11-06
Date received
2020-08-25
Regulation
884.4260
Classification name
Catheter, Balloon, Dilation Of Cervical Canal
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Eran Levit
Address
6 Columbia Dr. Amherst NH US 03031 03031

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PON  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K202433Aqueduct 200 Cervical Dilation Balloon CatheterGtimd, LLC2021-10-15
K190813CrossBay Cervical Dilator Catheter SystemCrossbay Medical2019-08-23
K160664Aqueduct 100 Cervical DilatorGtimd, LLC2016-08-01

Legacy Summary#

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FDA Review#

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