FDA 510(k)

Vanquish Water Vapor Ablation Device

Номер K: K252388 · 2025-11-26

Дата решения2025-11-26

Код продуктаKNS

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

Vanquish Water Vapor Ablation Device is the device name listed in this FDA 510(k) record. The listed applicant is Francis Medical, Inc.. It received FDA 510(k) clearance on 2025-11-26 under 510(k) number K252388. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Vanquish Water Vapor Ablation Device?

Vanquish Water Vapor Ablation Device is a medical device that received FDA 510(k) clearance on 2025-11-26. The listed applicant is Francis Medical, Inc.. The 510(k) number is K252388.

When did Vanquish Water Vapor Ablation Device receive FDA 510(k) clearance?

Vanquish Water Vapor Ablation Device received FDA 510(k) clearance on 2025-11-26, under 510(k) number K252388.

Who is the listed applicant for Vanquish Water Vapor Ablation Device?

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

What is the FDA product code for Vanquish Water Vapor Ablation Device?

The FDA product code for Vanquish Water Vapor Ablation Device is KNS.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: KNS)

K262460Rezum SystemBoston Scientific K260962SphincterotomeTaewoong Medical Co., Ltd.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems Corporation K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems Corporation K251104SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical

Официальный источник

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