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Pessary, Vaginal

FDA product code HHW · 38 cleared devices

Class 2 Obstetrics/Gynecology

Regulation: 21 CFR 884.3575
Review panel: OB
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-11-07 – 2026-01-20

HHW 2026-01-20

Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes

Applicant Cooper Surgical

K number K253698

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HHW 2025-04-11

CooperSurgical Milex® Pessaries

Applicant CooperSurgical, Inc.

K number K250438

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HHW 2024-12-17

Cntrl+ Bladder Support Pessary

Applicant Cntrl+, Inc.

K number K240798

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HHW 2024-05-21

Reia pessary

Applicant Reia, LLC

K number K232677

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HHW 2024-05-17

Yoni.Fit Bladder Support

Applicant Watkins-Conti Products, Inc.

K number K232525

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HHW 2024-04-03

Uresta®

Applicant Resilia, Inc.

K number K233548

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HHW 2024-03-06

Gynethotics™ Pessary

Applicant Cosm Medical

K number K231786

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HHW 2019-07-08

ProVate Vaginal Support

Applicant Contipi Medical , Ltd.

K number K190277

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HHW 2019-01-25

Revive Reusable Bladder Support

Applicant Rinovum Subsidiary 2, LLC

K number K183468

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HHW 2018-10-31

Panpac Flexi Shelf Pessary

Applicant Panpac Medical Corporation

K number K173351

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HHW 2016-07-14

Panpac Disposable Pessary Fitting Set

Applicant Panpac Medical Corporation

K number K153422

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HHW 2013-08-27

TIPI OTC

Applicant Contipi , Ltd.

K number K131198

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HHW 2010-07-22

PANPAC VAGINAL PESSARY

Applicant Panpac Medical Corporation

K number K092981

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HHW 2009-01-14

MODIFICATION TO URESTA PESSARY

Applicant Eastmed, Inc.

K number K083769

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HHW 2008-10-09

URESTA PESSARY

Applicant Eastmed, Inc.

K number K081385

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HHW 2006-06-09

TIPI

Applicant Contipi , Ltd.

K number K060526

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HHW 2004-05-28

KOLPEXIN SPHERE

Applicant Adamed , Ltd.

K number K032644

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HHW 2003-11-18

MARINA MEDICAL SILICONE PESSARY

Applicant Marina Medical Instruments, Inc.

K number K031463

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HHW 2002-05-16

MTI ST#1 SILICONE PESSARY

Applicant Medical Technology and Innovations, Inc.

K number K020512

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HHW 2002-02-11

PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE

Applicant Sims Portex , Ltd.

K number K012277

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HHW 2001-12-27

BIOTEQUE VAGINAL PESSARIES

Applicant Bioteque America, Inc.

K number K013289

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HHW 2000-09-18

PELVX GELLHORN VAGINAL PESSARY 603-608

Applicant Deschutes Medical Products, Inc.

K number K002329

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HHW 1999-12-13

MENTOR EVACARE VAGINAL PESSARIES

Applicant Mentor Corp.

K number K993308

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HHW 1999-05-24

PELVX INCONTINENCE DISH, MODEL 301-306

Applicant Deschutes Medical Products, Inc.

K number K990593

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HHW 1998-04-27

PELVX DONUT, PELVX CUBE

Applicant Deschutes Medical Products, Inc.

K number K974117

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HHW 1998-04-27

PELVX INCONTINENCE RING

Applicant Deschutes Medical Products, Inc.

K number K974116

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HHW 1998-04-27

PELVX RING, PELVX RING WITH SUPPORT

Applicant Deschutes Medical Products, Inc.

K number K974115

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HHW 1997-03-10

INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL

Applicant Johnson & Johnson Medical, Inc.

K number K965040

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HHW 1995-05-04

BLADDER NECK SUPPORT PROTHESIS FITTING KIT

Applicant Johnson & Johnson Medical, Inc.

K number K933654

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HHW 1995-05-04

VAGINAL CONTINENCE DEVICE

Applicant Johnson & Johnson Medical, Inc.

K number K930618

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HHW 1994-08-29

PESSARY FLEXIBLE SILICONE DONUT RING

Applicant Bioteque America, Inc.

K number K920747

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HHW 1992-10-23

FLEXIBLE SILICONE GELIHORN

Applicant Bioteque America, Inc.

K number K920187

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HHW 1990-12-07

INGLAT-O-BALL

Applicant Milex Products, Inc.

K number K904774

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HHW 1990-10-10

INFLAT-O-BALL

Applicant Milex Products, Inc.

K number K904026

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HHW 1989-03-29

GELLHORN PESSARY 33410 VARIOUS SIZES

Applicant Medi-Source, Inc.

K number K890565

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HHW 1988-10-03

FEMALE CONTINENCE DEVICE

Applicant Cook Ob/Gyn

K number K883721

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HHW 1978-11-06

DEVICE, FEMALE INCONTINENCE

Applicant Eschmann Bros. & Walsh , Ltd.

K number K781863

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HHW 1977-11-07

SILASTIC BRAND INTRAVAGINAL TARSETTE

Applicant Dow Corning Corp. Healthcare Industries Materials

K number K771548

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