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Aqueduct 200 Cervical Dilation Balloon Catheter

by Gtimd, LLC

510(k) K202433

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK202433 Date15 Oct 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
PON
Device Class
Class II
Regulation
21 CFR Part 884.4260
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Aqueduct 200 Cervical Dilation Balloon Catheter is a catheter used for dilation of the cervical canal. It is a Class 2 device, with a product code of PON, and is used in obstetrics and gynecology. The device is designed to facilitate cervical softening and dilation. It is used in various medical procedures, including treatment of cervical stenosis and IUD placement and removal.

The Aqueduct 200 Cervical Dilation Balloon Catheter is supplied as a single-use device. It is available with FDA 510(k) clearance, indicated by the clearance number K202433. The device is manufactured by Gtimd, LLC, and is regulated under the Traditional 510(k) pathway. It is stored and used in medical settings, including hospitals and clinics, and is subject to the regulations of the US FDA.

Other devices from Gtimd, LLC

Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Aqueduct 200 Cervical Dilation Balloon Catheter used for?

    The Aqueduct 200 Cervical Dilation Balloon Catheter is used for dilation of the cervical canal, facilitating cervical softening and dilation in various medical procedures, including treatment of cervical stenosis and IUD placement and removal.

  • Is the Aqueduct 200 Cervical Dilation Balloon Catheter a single-use device?

    Yes, the Aqueduct 200 Cervical Dilation Balloon Catheter is supplied as a single-use device, intended for one-time use in medical settings.

  • What regulatory pathway is the Aqueduct 200 Cervical Dilation Balloon Catheter regulated under?

    The Aqueduct 200 Cervical Dilation Balloon Catheter is regulated under the Traditional 510(k) pathway, with FDA 510(k) clearance indicated by the clearance number K202433.

  • In what medical settings is the Aqueduct 200 Cervical Dilation Balloon Catheter used?

    The Aqueduct 200 Cervical Dilation Balloon Catheter is used in medical settings, including hospitals and clinics, and is subject to the regulations of the US FDA.