FDA 510(k) Applications for Medical Device Product Code "HHW"
(Pessary, Vaginal)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K032644 | ADAMED LTD. | KOLPEXIN SPHERE | 05/28/2004 |
| K013289 | BIOTEQUE AMERICA, INC. | BIOTEQUE VAGINAL PESSARIES | 12/27/2001 |
| K240798 | Cntrl+ Inc. | Cntrl+ Bladder Support Pessary | 12/17/2024 |
| K060526 | CONTIPI LTD. | TIPI | 06/09/2006 |
| K131198 | CONTIPI LTD. | TIPI OTC | 08/27/2013 |
| K190277 | ConTIPI Medical Ltd. | ProVate Vaginal Support | 07/08/2019 |
| K250438 | CooperSurgical, Inc | CooperSurgical Milex« Pessaries | 04/11/2025 |
| K231786 | Cosm Medical | GynethoticsÖ Pessary | 03/06/2024 |
| K974117 | DESCHUTES MEDICAL PRODUCTS, INC. | PELVX DONUT, PELVX CUBE | 04/27/1998 |
| K002329 | DESCHUTES MEDICAL PRODUCTS, INC. | PELVX GELLHORN VAGINAL PESSARY 603-608 | 09/18/2000 |
| K990593 | DESCHUTES MEDICAL PRODUCTS, INC. | PELVX INCONTINENCE DISH, MODEL 301-306 | 05/24/1999 |
| K974116 | DESCHUTES MEDICAL PRODUCTS, INC. | PELVX INCONTINENCE RING | 04/27/1998 |
| K974115 | DESCHUTES MEDICAL PRODUCTS, INC. | PELVX RING, PELVX RING WITH SUPPORT | 04/27/1998 |
| K083769 | EASTMED INC. | MODIFICATION TO URESTA PESSARY | 01/14/2009 |
| K081385 | EASTMED INC. | URESTA PESSARY | 10/09/2008 |
| K132313 | EIS CORPORATION | PESSARY | 12/05/2014 |
| K965040 | JOHNSON & JOHNSON MEDICAL, INC. | INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL | 03/10/1997 |
| K031463 | MARINA MEDICAL INSTRUMENTS, INC. | MARINA MEDICAL SILICONE PESSARY | 11/18/2003 |
| K020512 | MEDICAL TECHNOLOGY AND INNOVATIONS, INC. | MTI ST#1 SILICONE PESSARY | 05/16/2002 |
| K993308 | MENTOR CORP. | MENTOR EVACARE VAGINAL PESSARIES | 12/13/1999 |
| K153422 | Panpac Medical Corporation | Panpac Disposable Pessary Fitting Set | 07/14/2016 |
| K173351 | Panpac Medical Corporation | Panpac Flexi Shelf Pessary | 10/31/2018 |
| K132670 | Panpac Medical Corporation | PANPAC INFLATABLE DOCUT PESSARY | 06/04/2014 |
| K092981 | Panpac Medical Corporation | PANPAC VAGINAL PESSARY | 07/22/2010 |
| K151413 | PROCTER & GAMBLE | Always/Tampax bladder supports | 12/18/2015 |
| K232677 | Reia, LLC | Reia pessary | 05/21/2024 |
| K233548 | Resilia Inc. | Uresta« | 04/03/2024 |
| K183468 | Rinovum Subsidiary 2, LLC | Revive Reusable Bladder Support | 01/25/2019 |
| K012277 | SIMS PORTEX LTD. | PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE | 02/11/2002 |
| K232525 | Watkins-Conti Products Inc. | Yoni.Fit Bladder Support | 05/17/2024 |
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