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HHW — Pessary, Vaginal Class II

FDA Device Classification

Classification Details

Product Code
HHW
Device Class
Class II
Regulation Number
884.3575
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253698cooper surgicalMilex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with SuppJanuary 20, 2026
K250438coopersurgicalCooperSurgical Milex® PessariesApril 11, 2025
K240798cntrl+Cntrl+ Bladder Support PessaryDecember 17, 2024
K232677reiaReia pessaryMay 21, 2024
K232525watkins-conti productsYoni.Fit Bladder SupportMay 17, 2024
K233548resiliaUresta®April 3, 2024
K231786cosm medicalGynethotics™ PessaryMarch 6, 2024
K190277contipi medicalProVate Vaginal SupportJuly 8, 2019
K183468rinovum subsidiary 2Revive Reusable Bladder SupportJanuary 25, 2019
K173351panpac medical corporationPanpac Flexi Shelf PessaryOctober 31, 2018
K153422panpac medical corporationPanpac Disposable Pessary Fitting SetJuly 14, 2016
K151413procter and gambleAlways/Tampax bladder supportsDecember 18, 2015
K132313eis corporationPESSARYDecember 5, 2014
K132670panpac medical corporationPANPAC INFLATABLE DOCUT PESSARYJune 4, 2014
K131198contipiTIPI OTCAugust 27, 2013
K092981panpac medical corporationPANPAC VAGINAL PESSARYJuly 22, 2010
K083769eastmedMODIFICATION TO URESTA PESSARYJanuary 14, 2009
K081385eastmedURESTA PESSARYOctober 9, 2008
K060526contipiTIPIJune 9, 2006
K032644adamedKOLPEXIN SPHEREMay 28, 2004