Product Code: HHW FDA class 2 21 CFR 884.3575

Pessary, Vaginal

Obstetrics/Gynecology

The Vaginal Pessary is an intravaginal supportive device, typically made of silicone or rubber, inserted into the vagina to mechanically support prolapsed pelvic organs or to manage stress urinary incontinence in women who are not surgical candidates or prefer conservative management. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HHW, regulated under 21 CFR 884.3575, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

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Years Active

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Basic Information

Product Code: HHW
Device Class: FDA class 2
Regulation Number: 884.3575
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 41 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253698	Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes	Jan 20, 2026	Substantially Equivalent	Cooper Surgical
K250438	CooperSurgical Milex® Pessaries	Apr 11, 2025	Substantially Equivalent	CooperSurgical, Inc.
K240798	Cntrl+ Bladder Support Pessary	Dec 17, 2024	Substantially Equivalent	Cntrl+, Inc.
K232677	Reia pessary	May 21, 2024	Substantially Equivalent	Reia, LLC
K232525	Yoni.Fit Bladder Support	May 17, 2024	Substantially Equivalent	Watkins-Conti Products, Inc.
K233548	Uresta®	Apr 03, 2024	Substantially Equivalent	Resilia, Inc.
K231786	Gynethotics Pessary	Mar 06, 2024	Substantially Equivalent	Cosm Medical
K190277	ProVate Vaginal Support	Jul 08, 2019	Substantially Equivalent	Contipi Medical , Ltd.
K183468	Revive Reusable Bladder Support	Jan 25, 2019	Substantially Equivalent	Rinovum Subsidiary 2, LLC
K173351	Panpac Flexi Shelf Pessary	Oct 31, 2018	Substantially Equivalent	Panpac Medical Corporation
K153422	Panpac Disposable Pessary Fitting Set	Jul 14, 2016	Substantially Equivalent	Panpac Medical Corporation
K151413	Always/Tampax bladder supports	Dec 18, 2015	Substantially Equivalent	Procter & Gamble
K132313	PESSARY	Dec 05, 2014	Substantially Equivalent	Eis Corporation
K132670	PANPAC INFLATABLE DOCUT PESSARY	Jun 04, 2014	Substantially Equivalent	Panpac Medical Corporation
K131198	TIPI OTC	Aug 27, 2013	Substantially Equivalent	Contipi , Ltd.
K092981	PANPAC VAGINAL PESSARY	Jul 22, 2010	Substantially Equivalent	Panpac Medical Corporation
K083769	MODIFICATION TO URESTA PESSARY	Jan 14, 2009	Substantially Equivalent	Eastmed, Inc.
K081385	URESTA PESSARY	Oct 09, 2008	Substantially Equivalent	Eastmed, Inc.
K060526	TIPI	Jun 09, 2006	Substantially Equivalent	Contipi , Ltd.
K032644	KOLPEXIN SPHERE	May 28, 2004	Substantially Equivalent	Adamed , Ltd.
K031463	MARINA MEDICAL SILICONE PESSARY	Nov 18, 2003	Substantially Equivalent	Marina Medical Instruments, Inc.
K020512	MTI ST#1 SILICONE PESSARY	May 16, 2002	Substantially Equivalent	Medical Technology and Innovations, Inc.
K012277	PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE	Feb 11, 2002	Substantially Equivalent	Sims Portex , Ltd.
K013289	BIOTEQUE VAGINAL PESSARIES	Dec 27, 2001	Substantially Equivalent	Bioteque America, Inc.
K002329	PELVX GELLHORN VAGINAL PESSARY 603-608	Sep 18, 2000	Substantially Equivalent	Deschutes Medical Products, Inc.
K993308	MENTOR EVACARE VAGINAL PESSARIES	Dec 13, 1999	Substantially Equivalent	Mentor Corp.
K990593	PELVX INCONTINENCE DISH, MODEL 301-306	May 24, 1999	Substantially Equivalent	Deschutes Medical Products, Inc.
K974117	PELVX DONUT, PELVX CUBE	Apr 27, 1998	Substantially Equivalent	Deschutes Medical Products, Inc.
K974116	PELVX INCONTINENCE RING	Apr 27, 1998	Substantially Equivalent	Deschutes Medical Products, Inc.
K974115	PELVX RING, PELVX RING WITH SUPPORT	Apr 27, 1998	Substantially Equivalent	Deschutes Medical Products, Inc.
K965040	INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL	Mar 10, 1997	Substantially Equivalent	Johnson & Johnson Medical, Inc.
K933654	BLADDER NECK SUPPORT PROTHESIS FITTING KIT	May 04, 1995	Substantially Equivalent	Johnson & Johnson Medical, Inc.
K930618	VAGINAL CONTINENCE DEVICE	May 04, 1995	Substantially Equivalent	Johnson & Johnson Medical, Inc.
K920747	PESSARY FLEXIBLE SILICONE DONUT RING	Aug 29, 1994	Substantially Equivalent	Bioteque America, Inc.
K920187	FLEXIBLE SILICONE GELIHORN	Oct 23, 1992	Substantially Equivalent	Bioteque America, Inc.
K904774	INGLAT-O-BALL	Dec 07, 1990	Substantially Equivalent	Milex Products, Inc.
K904026	INFLAT-O-BALL	Oct 10, 1990	Substantially Equivalent	Milex Products, Inc.
K890565	GELLHORN PESSARY 33410 VARIOUS SIZES	Mar 29, 1989	Substantially Equivalent	Medi-Source, Inc.
K883721	FEMALE CONTINENCE DEVICE	Oct 03, 1988	Substantially Equivalent	Cook Ob/Gyn
K781863	DEVICE, FEMALE INCONTINENCE	Nov 06, 1978	Unknown	Eschmann Bros. & Walsh , Ltd.
K771548	SILASTIC BRAND INTRAVAGINAL TARSETTE	Nov 07, 1977	Substantially Equivalent	Dow Corning Corp. Healthcare Industries Materials