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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Cosm Medical. It received FDA 510(k) clearance on 2024-03-06 under 510(k) 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. The listed applicant is Cosm Medical. The 510(k) number is K231786.

When did Gynethotics™ Pessary receive FDA 510(k) clearance?

Gynethotics™ Pessary received FDA 510(k) clearance on 2024-03-06, under 510(k) number K231786.

Who is the listed applicant for Gynethotics™ Pessary?

The FDA 510(k) record lists Cosm Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gynethotics™ Pessary?

The FDA product code for Gynethotics™ Pessary is HHW.

Related Devices (Code: HHW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253698Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage HolesCooper SurgicalK250438CooperSurgical Milex® PessariesCooperSurgical, Inc.K240798Cntrl+ Bladder Support PessaryCntrl+, Inc.K232677Reia pessaryReia, LLCK232525Yoni.Fit Bladder SupportWatkins-Conti Products, Inc.K233548Uresta®Resilia, Inc.

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.

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