FDA 510(k)

Sistema de Vapor de RF Médico Aqua

Número K: K211282 · 2021-05-27

Data da decisão2021-05-27

Código do produtoKNS

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Aqua Medical RF Vapor System is the device name listed in this FDA 510(k) record. The listed applicant is Aqua Medical, Inc.. It received FDA 510(k) clearance on 2021-05-27 under 510(k) number K211282. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Aqua Medical RF Vapor System?

Aqua Medical RF Vapor System is a medical device that received FDA 510(k) clearance on 2021-05-27. The listed applicant is Aqua Medical, Inc.. The 510(k) number is K211282.

When did Aqua Medical RF Vapor System receive FDA 510(k) clearance?

Aqua Medical RF Vapor System received FDA 510(k) clearance on 2021-05-27, under 510(k) number K211282.

Who is the listed applicant for Aqua Medical RF Vapor System?

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

What is the FDA product code for Aqua Medical RF Vapor System?

The FDA product code for Aqua Medical RF Vapor System is KNS.

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Outros registros que listam Aqua Medical, Inc. como candidato(a)

K251226Sistema de Ablação a Vapor de RF Médico Aqua K241271Sistema de Ablação a Vapor de RF Médico Aqua K213627RF Vapor System K183595Sistema de Vapor de RF Médico Aqua

Dispositivos Relacionados (Código: KNS)

K262460Rezum SystemBoston Scientific K260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.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

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