ClearanceBrief
510(k) K253698 · HHW Pessary, Vaginal

Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes

ApplicantCooper Surgical, Trumbull CT, US
DecisionSubstantially Equivalent, Jan 20, 2026
ReceivedNov 24, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K253698

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.