FDA.report

510(k) K253698

Device
Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes
Applicant
Cooper Surgical
510(k) number
K253698
Product code
HHW
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-20
Date received
2025-11-24
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
N

Related Records

Applicant Contact

Contact
Timothy Good
Address
95 Corporate Dr. Trumbull CT US 06611 06611

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code HHW

510(k)DeviceApplicantDecision date
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
K233548Uresta®Resilia, Inc.2024-04-03
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