FDA 510(k)

BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit

Número K: K254076 · 2026-05-29

Data da decisão2026-05-29

Código do produtoFCM

Comité consultivoGU

DecisãoUnknown

Resumo do dispositivo

BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2026-05-29 under 510(k) number K254076. The device is classified under product code FCM. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Perguntas frequentes

What is the BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit?

BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K254076.

When did BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit receive FDA 510(k) clearance?

BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit received FDA 510(k) clearance on 2026-05-29, under 510(k) number K254076.

Who is the listed applicant for BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit?

The FDA product code for BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit is FCM.

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Fonte oficial

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