FDA 510(k)

Coude Sleeved IC; Coude Plus Sleeved IC

Número K: K253295 · 2026-05-18

Data da decisão2026-05-18

Código do produtoEZD

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Coude Sleeved IC; Coude Plus Sleeved IC is the device name listed in this FDA 510(k) record. The listed applicant is Hollister Incorporated. It received FDA 510(k) clearance on 2026-05-18 under 510(k) number K253295. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Coude Sleeved IC; Coude Plus Sleeved IC?

Coude Sleeved IC; Coude Plus Sleeved IC is a medical device that received FDA 510(k) clearance on 2026-05-18. The listed applicant is Hollister Incorporated. The 510(k) number is K253295.

When did Coude Sleeved IC; Coude Plus Sleeved IC receive FDA 510(k) clearance?

Coude Sleeved IC; Coude Plus Sleeved IC received FDA 510(k) clearance on 2026-05-18, under 510(k) number K253295.

Who is the listed applicant for Coude Sleeved IC; Coude Plus Sleeved IC?

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

What is the FDA product code for Coude Sleeved IC; Coude Plus Sleeved IC?

The FDA product code for Coude Sleeved IC; Coude Plus Sleeved IC is EZD.

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Outros registros que listam Hollister Incorporated como candidato(a)

K251468Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)K233524Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized)K220667Sleeved IC K213575Female IC (Not Finalized)K211436Intermittent Catheter (Not Finalized)K193148VaPro Plus Pocket, VaPro Plus

Ver todos os 11 dispositivos →

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Fonte oficial

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