510(k) K002329
- Device
- PELVX GELLHORN VAGINAL PESSARY 603-608
- Applicant
- DESCHUTES MEDICAL PRODUCTS, INC.
- 510(k) number
- K002329
- Product code
- HHW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-09-18
- Date received
- 2000-08-01
- Regulation
- 884.3575
- Classification name
- Pessary, Vaginal
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DENISE BESTWICK
- Address
- 1011 SW Emkay Dr., Suite 104 Bend OR US 97702 97702
FDA Registration Numbers#
- 3015417614
- 3013557562
- 2084346
- 3005674485
- 3011529681
- 2431166
- 3011109575
- 3024374351
- 1226146
- 3000143502
- 3007137643
- 3031738269
- 3021815
- 3014755376
- 3024860690
- 2511556
- 3007289408
- 1450908
- 1123010
- 3020160672
- 3029906631
- 3010131137
- 2951215
- 3014295858
- 2025182
- 3025325116
- 3003968049
- 3019039128
- 1216677
- 3016608162
- 8040510
- 3003418325
- 9710006
- 3015895045
- 3031788248
- 3036802560
- 3007421149
- 9680721
- 3009513193
- 3003701733
Source Documents#
Other 510(k) Records For Product Code HHW #
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases