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FDA 510(k)

Yoni.Fit Bladder Support

K-Number: K232525 · 2024-05-17

ApplicantWatkins-Conti Products, Inc.
Decision Date2024-05-17
Product CodeHHW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Yoni.Fit Bladder Support is the device name listed in this FDA 510(k) record. The listed applicant is Watkins-Conti Products, Inc.. It received FDA 510(k) clearance on 2024-05-17 under 510(k) number K232525. 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 Yoni.Fit Bladder Support?

Yoni.Fit Bladder Support is a medical device that received FDA 510(k) clearance on 2024-05-17. The listed applicant is Watkins-Conti Products, Inc.. The 510(k) number is K232525.

When did Yoni.Fit Bladder Support receive FDA 510(k) clearance?

Yoni.Fit Bladder Support received FDA 510(k) clearance on 2024-05-17, under 510(k) number K232525.

Who is the listed applicant for Yoni.Fit Bladder Support?

The FDA 510(k) record lists Watkins-Conti Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Yoni.Fit Bladder Support?

The FDA product code for Yoni.Fit Bladder Support 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, LLCK233548Uresta®Resilia, Inc.K231786Gynethotics™ PessaryCosm Medical

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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