Gynethotics Pessary
K-Number: K231786 · 2024-03-06
ApplicantCosm Medical
Decision Date2024-03-06
Product CodeHHW
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Gynethotics Pessary is a medical device manufactured by Cosm Medical. It received FDA 510(k) clearance on 2024-03-06 under approval number K231786. The device is classified under product code HHW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Gynethotics Pessary?
Gynethotics Pessary is a medical device that received FDA 510(k) clearance on 2024-03-06. It is manufactured by Cosm Medical. The 510(k) number is K231786.
When was Gynethotics Pessary approved by the FDA?
Gynethotics Pessary received FDA 510(k) clearance on 2024-03-06, under approval number K231786.
What company makes Gynethotics Pessary?
Gynethotics Pessary is manufactured by Cosm Medical.
What is the FDA product code for Gynethotics Pessary?
The FDA product code for Gynethotics Pessary is HHW.
Related Devices (Code: HHW)
K153422Panpac Disposable Pessary Fitting SetPanpac Medical Corporation
K173351Panpac Flexi Shelf PessaryPanpac Medical Corporation
K190277ProVate Vaginal SupportContipi Medical , Ltd.
K183468Revive Reusable Bladder SupportRinovum Subsidiary 2, LLC
K240798Cntrl+ Bladder Support PessaryCntrl+, Inc.
K232677Reia pessaryReia, LLC
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.