Cleared Traditional

Gynethotics? Pessary

K231786 · Cosm Medical · Obstetrics & Gynecology

Mar 2024

Decision

260d

Days

Class 2

Risk

About This 510(k) Submission

K231786 is an FDA 510(k) clearance for the Gynethotics? Pessary, a Pessary, Vaginal (Class II — Special Controls, product code HHW), submitted by Cosm Medical (Toronto, CA). The FDA issued a Cleared decision on March 6, 2024, 260 days after receiving the submission on June 20, 2023. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.3575.

Submission Details

510(k) Number	K231786 FDA.gov
FDA Decision	Cleared 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