Cleared Abbreviated

K160664 - Aqueduct 100 Cervical Dilator (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K160664 · Gtimd, LLC · Obstetrics & Gynecology device
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Aug 2016
Decision
145d
Days
Class 2
Risk

K160664 is an FDA 510(k) clearance for the Aqueduct 100 Cervical Dilator. Classified as Catheter, Balloon, Dilation Of Cervical Canal (product code PON), Class II - Special Controls.

Submitted by Gtimd, LLC (Amherst, US). The FDA issued a Cleared decision on August 1, 2016 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4260 - the FDA obstetrics and gynecology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

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Submission Details

510(k) Number K160664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2016
Decision Date August 01, 2016
Days to Decision 145 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 160d · This submission: 145d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code PON Catheter, Balloon, Dilation Of Cervical Canal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4260
Definition Mechanical Dilation And Softening Of The Cervix.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.