Cleared Traditional

Gynethotics™ Pessary (K231786) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231786 · Cosm Medical · Obstetrics & Gynecology device
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Mar 2024
Decision
260d
Days
Class 2
Risk

K231786 is an FDA 510(k) clearance for the Gynethotics™ Pessary. Classified as Pessary, Vaginal (product code HHW), Class II - Special Controls.

Submitted by Cosm Medical (Toronto, CA). The FDA issued a Cleared decision on March 6, 2024 after a review of 260 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.3575 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cosm Medical devices

Submission Details

510(k) Number K231786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2023
Decision Date March 06, 2024
Days to Decision 260 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 160d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HHW Pessary, Vaginal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.3575
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.

Regulatory Peers - HHW Pessary, Vaginal

All 9
Devices cleared under the same product code (HHW) and FDA review panel - the closest regulatory comparables to K231786.
Reia pessary
K232677 · Reia, LLC · May 2024
Yoni.Fit Bladder Support
K232525 · Watkins-Conti Products, Inc. · May 2024
Uresta®
K233548 · Resilia, Inc. · Apr 2024
ProVate Vaginal Support
K190277 · Contipi Medical , Ltd. · Jul 2019
Revive Reusable Bladder Support
K183468 · Rinovum Subsidiary 2, LLC · Jan 2019
Panpac Flexi Shelf Pessary
K173351 · Panpac Medical Corporation · Oct 2018