Gynethotics
Gynethotics pessaries are removable devices placed in the vaginal cavity. The FDA filing describes their intended use as a nonsurgical alternative for pelvic organ prolapse and pelvic…
Gynethotics pessaries are removable devices placed in the vaginal cavity. The FDA filing describes their intended use as a nonsurgical alternative for pelvic organ prolapse and pelvic relaxation symptoms in adults.
The stated intended use includes pelvic relaxation with or without urinary incontinence. The specific indications vary by pessary shape and configuration in the filing.
Listed Item
The Gynethotics™ Pessary is a patient-specific, made-to-order gynecological prosthetic device designed for the conservative management of pelvic floor disorders. Fabricated from biocompatible silicone material, each device is customized using patient-specific anatomical measurements analyzed via proprietary cloud-based digital gynecology software to optimize physical fit. The device is a removable structure placed inside the vaginal cavity to provide localized, non-invasive mechanical support to pelvic organs. It is indicated for the temporary or long-term management of pelvic organ prolapse (including uterine prolapse and cystocele), stress urinary incontinence, and associated pelvic floor deficiencies. The device is supplied non-sterile.
Shapes and Configurations
The filing describes four general shapes: Ring, Gellhorn, Marland and Cube. Each shape is offered with configurable features and dimensions, as determined by the clinician.
Who Else Makes It
All of them in Guangdong. 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| B&A Precision Silicone Rubber (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Guangzhou Fame Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 1 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
Record
| Listed by | Cosm Medical, Canada |
|---|---|
| FDA product code | HHW |
| Device type | Pessary, Vaginal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.3575 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K231786 |
| Record published | 2026-06-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Patient-Specific | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pessary, Vaginal | Panpac Medical Corporation | 628 |
| Milex | Coopersurgical, Inc. | 592 |
| Bioteque America, Inc. | Bioteque America, Inc. | 221 |
| Bioteque | Bioteque Taiwan Ltd. | 209 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 189 |
| HNM Women Care | HNM Stainless, LLC. | 187 |
| Medline | Medline Industries, Inc. | 162 |
| Marina Medical | Marina Medical Instruments, Inc. | 144 |
| EvaCare | Personal Medical Corp. | 128 |
| Hayden Medical | Hayden Medical Inc | 81 |
| Premier | Premier Dental Products Co. | 58 |
| LTL Medical | Bioteque Taiwan Ltd. | 56 |
Showing 12 of 180. All products under Pessary, Vaginal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231786 | 2024-03-06 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.