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FDA 510(k)

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

Número K: K253698 · 2026-01-20

RequerenteCooper Surgical
Data da decisão2026-01-20
Código do produtoHHW
Comité consultivoOB
DecisãoSubstantially Equivalent

Resumo do dispositivo

Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Surgical. It received FDA 510(k) clearance on 2026-01-20 under 510(k) number K253698. The device is classified under product code HHW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes?

Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes is a medical device that received FDA 510(k) clearance on 2026-01-20. The listed applicant is Cooper Surgical. The 510(k) number is K253698.

When did Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes receive FDA 510(k) clearance?

Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes received FDA 510(k) clearance on 2026-01-20, under 510(k) number K253698.

Who is the listed applicant for Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes?

The FDA 510(k) record lists Cooper Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes?

The FDA product code for Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes is HHW.

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Dispositivos Relacionados (Código: HHW)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K250438CooperSurgical Milex® PessariesCooperSurgical, Inc.K240798Cntrl+ Bladder Support PessaryCntrl+, Inc.K232677Reia pessaryReia, LLCK232525Yoni.Fit Bladder SupportWatkins-Conti Products, Inc.K233548Uresta®Resilia, Inc.K231786Gynethotics™ PessaryCosm Medical

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