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FDA 510(k)

Reia pessary

K-Number: K232677 · 2024-05-21

ApplicantReia, LLC
Decision Date2024-05-21
Product CodeHHW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Reia pessary is the device name listed in this FDA 510(k) record. The listed applicant is Reia, LLC. It received FDA 510(k) clearance on 2024-05-21 under 510(k) number K232677. 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 Reia pessary?

Reia pessary is a medical device that received FDA 510(k) clearance on 2024-05-21. The listed applicant is Reia, LLC. The 510(k) number is K232677.

When did Reia pessary receive FDA 510(k) clearance?

Reia pessary received FDA 510(k) clearance on 2024-05-21, under 510(k) number K232677.

Who is the listed applicant for Reia pessary?

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

What is the FDA product code for Reia pessary?

The FDA product code for Reia pessary is HHW.

Related Clinical Trials

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.

NCT06634459POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse TreatmentACTIVE_NOT_RECRUITING

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.K232525Yoni.Fit Bladder SupportWatkins-Conti Products, Inc.K233548Uresta®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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