Pessary, Vaginal
FDA product code HHW · Class II (moderate risk) · 21 CFR 884.3575 · Obstetrics/Gynecology
41510(k) clearances
0PMA approvals
17recalls
Manufacturers
- Deschutes Medical Products, Inc. 5
- Panpac Medical Corporation 4
- Bioteque America, Inc. 3
- Johnson & Johnson Medical, Inc. 3
- Milex Products, Inc. 2
- Eastmed, Inc. 2
- Contipi , Ltd. 2
- Medical Technology and Innovations, Inc. 1
- Cooper Surgical, Inc. 1
- Contipi Medical , Ltd. 1
- Rinovum Subsidiary 2, LLC 1
- Procter & Gamble Co. 1
- Eis Corporation 1
- Adamed , Ltd. 1
- Marina Medical Instruments, Inc. 1
- Dow Corning Corp. Healthcare Industries Materials 1
- Sims Portex, Inc. 1
- Mentor Corp. 1
- Medi-Source, Inc. 1
- Cook Ob/Gyn 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253698 | Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support…HHW · Traditional | Cooper Surgical | 01/20/2026SE |
| K250438 | CooperSurgical Milex® PessariesHHW · Traditional | CooperSurgical, Inc. | 04/11/2025SE |
| K240798 | Cntrl+ Bladder Support PessaryHHW · Traditional | Cntrl+, Inc. | 12/17/2024SE |
| K232677 | Reia pessaryHHW · Traditional | Reia, LLC | 05/21/2024SE |
| K232525 | Yoni.Fit Bladder SupportHHW · Traditional | Watkins-Conti Products, Inc. | 05/17/2024SE |
| K233548 | Uresta®HHW · Traditional | Resilia, Inc. | 04/03/2024SE |
| K231786 | Gynethotics PessaryHHW · Traditional | Cosm Medical | 03/06/2024SE |
| K190277 | ProVate Vaginal SupportHHW · Traditional | Contipi Medical , Ltd. | 07/08/2019SE |
| K183468 | Revive Reusable Bladder SupportHHW · Traditional | Rinovum Subsidiary 2, LLC | 01/25/2019SE |
| K173351 | Panpac Flexi Shelf PessaryHHW · Abbreviated | Panpac Medical Corporation | 10/31/2018SE |
| K153422 | Panpac Disposable Pessary Fitting SetHHW · Special | Panpac Medical Corporation | 07/14/2016SE |
| K151413 | Always/Tampax bladder supportsHHW · Traditional | Procter & Gamble | 12/18/2015SE |
| K132313 | PessaryHHW · Traditional | Eis Corporation | 12/05/2014SE |
| K132670 | Panpac Inflatable Docut PessaryHHW · Traditional | Panpac Medical Corporation | 06/04/2014SE |
| K131198 | Tipi OTCHHW · Traditional | Contipi , Ltd. | 08/27/2013SE |
| K092981 | Panpac Vaginal PessaryHHW · Traditional | Panpac Medical Corporation | 07/22/2010SE |
| K083769 | Modification to Uresta PessaryHHW · Special | Eastmed, Inc. | 01/14/2009SE |
| K081385 | Uresta PessaryHHW · Traditional | Eastmed, Inc. | 10/09/2008SE |
| K060526 | TipiHHW · Traditional | Contipi , Ltd. | 06/09/2006SE |
| K032644 | Kolpexin SphereHHW · Traditional | Adamed , Ltd. | 05/28/2004SE |
| K031463 | Marina Medical Silicone PessaryHHW · Traditional | Marina Medical Instruments, Inc. | 11/18/2003SE |
| K020512 | Mti ST#1 Silicone PessaryHHW · Traditional | Medical Technology and Innovations, Inc. | 05/16/2002SE |
| K012277 | Portex Ring Pessary Pvc-Non Sterile; Portex Ring Pessary Polythene- Non SterileHHW · Traditional | Sims Portex , Ltd. | 02/11/2002SE |
| K013289 | Bioteque Vaginal PessariesHHW · Traditional | Bioteque America, Inc. | 12/27/2001SE |
| K002329 | Pelvx Gellhorn Vaginal Pessary 603-608HHW · Traditional | Deschutes Medical Products, Inc. | 09/18/2000SE |
| K993308 | Mentor Evacare Vaginal PessariesHHW · Traditional | Mentor Corp. | 12/13/1999SE |
| K990593 | Pelvx Incontinence Dish, Model 301-306HHW · Traditional | Deschutes Medical Products, Inc. | 05/24/1999SE |
| K974117 | Pelvx Donut, Pelvx CubeHHW · Traditional | Deschutes Medical Products, Inc. | 04/27/1998SE |
| K974116 | Pelvx Incontinence RingHHW · Traditional | Deschutes Medical Products, Inc. | 04/27/1998SE |
| K974115 | Pelvx Ring, Pelvx Ring with SupportHHW · Traditional | Deschutes Medical Products, Inc. | 04/27/1998SE |
| K965040 | Introl Bladder Neck Support Prosthesis with Removal ToolHHW · Traditional | Johnson & Johnson Medical, Inc. | 03/10/1997SE |
| K933654 | Bladder Neck Support Prothesis Fitting KitHHW · Traditional | Johnson & Johnson Medical, Inc. | 05/04/1995SE |
| K930618 | Vaginal Continence DeviceHHW · Traditional | Johnson & Johnson Medical, Inc. | 05/04/1995SE |
| K920747 | Pessary Flexible Silicone Donut RingHHW · Traditional | Bioteque America, Inc. | 08/29/1994SE |
| K920187 | Flexible Silicone GelihornHHW · Traditional | Bioteque America, Inc. | 10/23/1992SE |
| K904774 | Inglat-O-BallHHW · Traditional | Milex Products, Inc. | 12/07/1990SE |
| K904026 | Inflat-O-BallHHW · Traditional | Milex Products, Inc. | 10/10/1990SE |
| K890565 | Gellhorn Pessary 33410 Various SizesHHW · Traditional | Medi-Source, Inc. | 03/29/1989SE |
| K883721 | Female Continence DeviceHHW · Traditional | Cook Ob/Gyn | 10/03/1988SE |
| K781863 | Device, Female IncontinenceHHW · Traditional | Eschmann Bros. & Walsh , Ltd. | 11/06/1978SESP |
| K771548 | Silastic Brand Intravaginal TarsetteHHW · Traditional | Dow Corning Corp. Healthcare Industries Materials | 11/07/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1631-2022 Class II | COOPER SURGICAL Milex PESSARY, RING MILEX INCONT FLEXIBLE SZ6 1 3/4" Catalog # MXPCON06Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-1152-2021 Class II | Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem…The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), instead of a… | CooperSurgical, Inc. | 01/21/2021Terminated |
| Z-1952-2019 Class II | Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder…The product is unable to meet the use life of 31 cycles and may split or crack at the base of the "petals"… | Rinovum Women's Health | 05/02/2019Terminated |
| Z-2054-2017 Class II | CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part…The current secondary packaging, a box, incorrectly states that the product is latex free. The product is… | CooperSurgical, Inc. | 04/10/2017Terminated |
| Z-0253-2016 Class III | MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product Usage:…The products have been identified to have incorrect size prints on the MILEX PESSARY KIT packaging. While… | CooperSurgical, Inc. | 09/14/2015Terminated |
| Z-1239-2015 Class II | CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02Incorrect size printed on the Milex Pessary Kit packaging label | CooperSurgical, Inc. | 02/09/2015Terminated |
| Z-0208-2015 Class III | CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01…Incorrect expiration date printed on the MILEX PESSARY KIT packaging | CooperSurgical, Inc. | 09/30/2014Terminated |
| Z-0207-2015 Class III | CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01…Incorrect expiration date printed on the MILEX PESSARY KIT packaging | CooperSurgical, Inc. | 09/30/2014Terminated |
| Z-1012-2013 Class III | Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number: MXKPECH00…Pessary mislabeled outer package may not reflect the size of the product contained in the package | Cooper Surgical, Inc. | 02/26/2013Terminated |
| Z-1011-2013 Class III | Cooper Surgical Cube Pessary 1 5/8"", 41mm. Milex Part Number: MXKPEC04 A pessary is a…Pessary mislabeled outer package may not reflect the size of the product contained in the package | Cooper Surgical, Inc. | 02/26/2013Terminated |
| Z-1010-2013 Class III | Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE3- A pessary…Pessary mislabeled outer package may not reflect the size of the product contained in the package | Cooper Surgical, Inc. | 02/26/2013Terminated |
| Z-1009-2013 Class III | Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number: MXPGE2-3/4 A…Pessary mislabeled outer package may not reflect the size of the product contained in the package | Cooper Surgical, Inc. | 02/26/2013Terminated |
| Z-1008-2013 Class III | Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXPCOND00…Pessary mislabeled outer package may not reflect the size of the product contained in the package | Cooper Surgical, Inc. | 02/26/2013Terminated |
| Z-1007-2013 Class III | Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number:…Pessary mislabeled outer package may not reflect the size of the product contained in the package | Cooper Surgical, Inc. | 02/26/2013Terminated |
| Z-1006-2013 Class III | Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex Part Number:…Pessary mislabeled outer package may not reflect the size of the product contained in the package | Cooper Surgical, Inc. | 02/26/2013Terminated |
| Z-1005-2013 Class III | Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex :Part Number:…Pessary mislabeled outer package may not reflect the size of the product contained in the package | Cooper Surgical, Inc. | 02/26/2013Terminated |
| Z-1004-2013 Class III | Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex Part Number:…Pessary mislabeled outer package may not reflect the size of the product contained in the package | Cooper Surgical, Inc. | 02/26/2013Terminated |