Milex Incontinence Dish Pessaries +3 more— 510(k) K253698
Substantially EquivalentCooper Surgical
FDA 510(k) clearance K253698 for Milex Incontinence Dish Pessaries +3 more, Substantially Equivalent on 2026-01-20. Applicant: Cooper Surgical. Device class: 2.
Clearance details
- Device name as filed
- Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes
- Applicant
- Cooper Surgical
- Product code
- Code HHW
- Device class
- Class 2
- Regulation
- 21 CFR 884.3575
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Trumbull, CT, US
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Adverse events under product code HHW
product code HHW- Malfunction
- 485
- Total
- 485
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.