Aqueduct 100 Plus Cervical Dilation Balloon Catheter— 510(k) K202427

Name: FDA 510(k) clearance K202427
Creator: U.S. Food and Drug Administration
Published: 2020-11-06

Substantially Equivalent

Gtimd, LLC

FDA 510(k) clearance K202427 for Aqueduct 100 Plus Cervical Dilation Balloon Catheter, Substantially Equivalent on 2020-11-06. Applicant: Gtimd, LLC. Device class: 2.

Clearance details

Applicant: Gtimd, LLC
Product code: Code PON
Device class: Class 2
Regulation: 21 CFR 884.4260
Advisory panel: Obstetrics/Gynecology
Date received: 2020-08-25
Decision date: 2020-11-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Amherst, NH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PON

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K202433 — Aqueduct 200 Cervical Dilation Balloon Catheter2021-10-15
K190813 — CrossBay Cervical Dilator Catheter System2019-08-23
K160664 — Aqueduct 100 Cervical Dilator2016-08-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.