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510(k) K202427

Aqueduct 100 Plus Cervical Dilation Balloon Catheter by Gtimd, LLC — Product Code PON

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 6, 2020
Date Received: August 25, 2020
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Catheter, Balloon, Dilation Of Cervical Canal
Device Class: Class II
Regulation Number: 884.4260
Review Panel: OB
Submission Type

Mechanical dilation and softening of the cervix.