FDA.report

510(k) K233548

Device
Uresta®
Applicant
Resilia, Inc.
510(k) number
K233548
Product code
HHW
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-03
Date received
2023-11-03
Regulation
884.3575
Classification name
Pessary, Vaginal
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Sam Imbeault
Address
644 Main St. Suite S400, P.O. Box 1368 Moncton CA E1C 1E2 E1C 1E2

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code HHW

510(k)DeviceApplicantDecision date
K253698Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage HolesCooper Surgical2026-01-20
K250438CooperSurgical Milex® PessariesCooperSurgical, Inc.2025-04-11
K240798Cntrl+ Bladder Support PessaryCntrl+, Inc.2024-12-17
K232677Reia pessaryReia, LLC2024-05-21
K232525Yoni.Fit Bladder SupportWatkins-Conti Products, Inc.2024-05-17
K231786Gynethotics™ PessaryCosm Medical2024-03-06
K190277ProVate Vaginal SupportContipi Medical , Ltd.2019-07-08
K183468Revive Reusable Bladder SupportRinovum Subsidiary 2, LLC2019-01-25
K173351Panpac Flexi Shelf PessaryPanpac Medical Corporation2018-10-31
K153422Panpac Disposable Pessary Fitting SetPanpac Medical Corporation2016-07-14
K151413Always/Tampax bladder supportsProcter & Gamble2015-12-18
K132313PESSARYEis Corporation2014-12-05
K132670PANPAC INFLATABLE DOCUT PESSARYPanpac Medical Corporation2014-06-04
K131198TIPI OTCContipi , Ltd.2013-08-27
K092981PANPAC VAGINAL PESSARYPanpac Medical Corporation2010-07-22