FDA 510(k)

RENASYS DYNAFLOW Kit (66807741)

Número K: K261338 · 2026-09-11

Data da decisão2026-09-11

Código do produtoOMP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

RENASYS DYNAFLOW Kit (66807741) is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical, Ltd.. It received FDA 510(k) clearance on 2026-09-11 under 510(k) number K261338. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the RENASYS DYNAFLOW Kit (66807741)?

RENASYS DYNAFLOW Kit (66807741) is a medical device that received FDA 510(k) clearance on 2026-09-11. The listed applicant is Smith & Nephew Medical, Ltd.. The 510(k) number is K261338.

When did RENASYS DYNAFLOW Kit (66807741) receive FDA 510(k) clearance?

RENASYS DYNAFLOW Kit (66807741) received FDA 510(k) clearance on 2026-09-11, under 510(k) number K261338.

Who is the listed applicant for RENASYS DYNAFLOW Kit (66807741)?

The FDA 510(k) record lists Smith & Nephew Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RENASYS DYNAFLOW Kit (66807741)?

The FDA product code for RENASYS DYNAFLOW Kit (66807741) is OMP.

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Fonte oficial

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