FDA 510(k)

swiftPro System (SWF-SPS); Swift System (SWF-SYS)

Número K: K250718 · 2025-08-08

Data da decisão2025-08-08

Código do produtoNEY

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

swiftPro System (SWF-SPS); Swift System (SWF-SYS) is the device name listed in this FDA 510(k) record. The listed applicant is Emblation Limited. It received FDA 510(k) clearance on 2025-08-08 under 510(k) number K250718. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the swiftPro System (SWF-SPS); Swift System (SWF-SYS)?

swiftPro System (SWF-SPS); Swift System (SWF-SYS) is a medical device that received FDA 510(k) clearance on 2025-08-08. The listed applicant is Emblation Limited. The 510(k) number is K250718.

When did swiftPro System (SWF-SPS); Swift System (SWF-SYS) receive FDA 510(k) clearance?

swiftPro System (SWF-SPS); Swift System (SWF-SYS) received FDA 510(k) clearance on 2025-08-08, under 510(k) number K250718.

Who is the listed applicant for swiftPro System (SWF-SPS); Swift System (SWF-SYS)?

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

What is the FDA product code for swiftPro System (SWF-SPS); Swift System (SWF-SYS)?

The FDA product code for swiftPro System (SWF-SPS); Swift System (SWF-SYS) is NEY.

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Outros registros que listam Emblation Limited como candidato(a)

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Fonte oficial

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