Product code HHW
- Device name
- Pessary, Vaginal
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.3575
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253698 | Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes | Cooper Surgical | 2026-01-20 |
| K250438 | CooperSurgical Milex® Pessaries | CooperSurgical, Inc. | 2025-04-11 |
| K240798 | Cntrl+ Bladder Support Pessary | Cntrl+, Inc. | 2024-12-17 |
| K232677 | Reia pessary | Reia, LLC | 2024-05-21 |
| K232525 | Yoni.Fit Bladder Support | Watkins-Conti Products, Inc. | 2024-05-17 |
| K233548 | Uresta® | Resilia, Inc. | 2024-04-03 |
| K231786 | Gynethotics™ Pessary | Cosm Medical | 2024-03-06 |
| K190277 | ProVate Vaginal Support | Contipi Medical , Ltd. | 2019-07-08 |
| K183468 | Revive Reusable Bladder Support | Rinovum Subsidiary 2, LLC | 2019-01-25 |
| K173351 | Panpac Flexi Shelf Pessary | Panpac Medical Corporation | 2018-10-31 |
| K153422 | Panpac Disposable Pessary Fitting Set | Panpac Medical Corporation | 2016-07-14 |
| K151413 | Always/Tampax bladder supports | Procter & Gamble | 2015-12-18 |
| K132313 | PESSARY | Eis Corporation | 2014-12-05 |
| K132670 | PANPAC INFLATABLE DOCUT PESSARY | Panpac Medical Corporation | 2014-06-04 |
| K131198 | TIPI OTC | Contipi , Ltd. | 2013-08-27 |
| K092981 | PANPAC VAGINAL PESSARY | Panpac Medical Corporation | 2010-07-22 |
| K083769 | MODIFICATION TO URESTA PESSARY | Eastmed, Inc. | 2009-01-14 |
| K081385 | URESTA PESSARY | Eastmed, Inc. | 2008-10-09 |
| K060526 | TIPI | Contipi , Ltd. | 2006-06-09 |
| K032644 | KOLPEXIN SPHERE | Adamed , Ltd. | 2004-05-28 |
| K031463 | MARINA MEDICAL SILICONE PESSARY | Marina Medical Instruments, Inc. | 2003-11-18 |
| K020512 | MTI ST#1 SILICONE PESSARY | Medical Technology and Innovations, Inc. | 2002-05-16 |
| K012277 | PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE | Sims Portex , Ltd. | 2002-02-11 |
| K013289 | BIOTEQUE VAGINAL PESSARIES | Bioteque America, Inc. | 2001-12-27 |
| K002329 | PELVX GELLHORN VAGINAL PESSARY 603-608 | Deschutes Medical Products, Inc. | 2000-09-18 |
| K993308 | MENTOR EVACARE VAGINAL PESSARIES | Mentor Corp. | 1999-12-13 |
| K990593 | PELVX INCONTINENCE DISH, MODEL 301-306 | Deschutes Medical Products, Inc. | 1999-05-24 |
| K974115 | PELVX RING, PELVX RING WITH SUPPORT | Deschutes Medical Products, Inc. | 1998-04-27 |
| K974116 | PELVX INCONTINENCE RING | Deschutes Medical Products, Inc. | 1998-04-27 |
| K974117 | PELVX DONUT, PELVX CUBE | Deschutes Medical Products, Inc. | 1998-04-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04719894431000 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894431147 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894431130 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894431123 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894431116 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894431109 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894431093 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894431086 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894431079 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894431062 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894431055 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894431048 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894431031 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894431024 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894431017 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894430003 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894430997 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894430980 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894430973 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894430966 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894430959 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894430942 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894430935 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894430928 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894430911 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894430904 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894430591 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894430584 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894430034 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894430010 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |