FDA 510(k)

Uresta®

K-Number: K233548 · 2024-04-03

Decision Date2024-04-03

Product CodeHHW

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Uresta® is the device name listed in this FDA 510(k) record. The listed applicant is Resilia, Inc.. It received FDA 510(k) clearance on 2024-04-03 under 510(k) number K233548. 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 Uresta®?

Uresta® is a medical device that received FDA 510(k) clearance on 2024-04-03. The listed applicant is Resilia, Inc.. The 510(k) number is K233548.

When did Uresta® receive FDA 510(k) clearance?

Uresta® received FDA 510(k) clearance on 2024-04-03, under 510(k) number K233548.

Who is the listed applicant for Uresta®?

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

What is the FDA product code for Uresta®?

The FDA product code for Uresta® 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.

NCT07706491A Study of Two Versions of the Uresta Pessary Handle for Women With Stress Urinary IncontinenceCOMPLETED

Related Devices (Code: HHW)

K253698Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage HolesCooper Surgical K250438CooperSurgical Milex® PessariesCooperSurgical, Inc.K240798Cntrl+ Bladder Support PessaryCntrl+, Inc.K232677Reia pessaryReia, LLC K232525Yoni.Fit Bladder SupportWatkins-Conti Products, Inc.K231786Gynethotics™ PessaryCosm Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.