Aqueduct 200 Cervical Dilation Balloon Catheter— 510(k) K202433

Substantially Equivalent

Gtimd, LLC

FDA 510(k) clearance K202433 for Aqueduct 200 Cervical Dilation Balloon Catheter, Substantially Equivalent on 2021-10-15. Applicant: Gtimd, LLC.

Clearance details

Applicant: Gtimd, LLC
Product code: Code PON
Advisory panel: Obstetrics/Gynecology
Date received: 2020-08-25
Decision date: 2021-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amherst, NH, US

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