Cooper Surgical · Class II · Cleared Jan 20, 2026
| K-number | K253698 |
| Device name | Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes |
| Applicant | Cooper Surgical |
| Product code | HHW |
| Device class | Class II |
| Decision date | Jan 20, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 884.3575 |
The CooperSurgical Milex™ Pessaries are vaginal devices made of liquid silicone designed to provide support to pelvic organs when inserted into the vagina. They are available in multiple shapes and sizes: Incontinence Dish Pessaries (with and without support) for treating uterine prolapse, cystocele, rectocele, and stress urinary incontinence; and Cube Pessaries (with and without drainage holes) for nonsurgical management of Stage III pelvic organ prolapse. The devices are provided non-sterile for single-patient, multiple-use application.
The Milex™ Pessaries are manufactured from liquid silicone using injection molding, available in multiple shapes and sizes (Dish: 2.125–3.375 inches; Cube: 1.00–2.25 inches), and colored pink for identification. The material composition differs from predicate devices in silicone and additive formulations, but these differences do not raise new safety or effectiveness questions. Size ranges remain within the dimensional envelopes of predicate devices.
Biocompatibility testing per ISO 10993-1 (2023 FDA guidance), including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2021), irritation (ISO 10993-23:2023), subacute/subchronic toxicity (ISO 10993-11:2017, 10993-6:2016), pyrogenicity (ISO 10993-11:2017), acute systemic toxicity (ISO 10993-11:2017), genotoxicity (ISO 10993-3:2014, 10993-33:2015, 10993-11:2017), implantation (ISO 10993-6:2016), and chronic toxicity (ISO 10993-6:2016, 10993-11:2017). Shelf life and use life tested per ASTM F1980.
The subject devices share identical intended use, principles of operation, and fundamental scientific technology with predicate devices EIS Vaginal Pessaries (K132313) and Mentor EvaCare™ Vaginal Pessaries (K993308)—all are removable silicone structures for nonsurgical pelvic organ support. Design differences in sizing and material formulation do not raise new questions of safety or effectiveness, as sizes remain within established dimensional ranges and biocompatibility testing demonstrates non-cytotoxic, non-sensitizing, and non-toxic properties. A prior CooperSurgical reference device (K250438) confirms that bundled pessary shapes and expanded indications are consistent with cleared 510(k) pessary submissions.
View the full FDA submission: accessdata.fda.gov