FDA 510(k)

Sistema de Ablación de Vapor RF Médico Aqua, Agua Médica

N.º K: K241271 · 2024-12-12

Fecha de decisión2024-12-12

Código de productoKNS

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Aqua Medical RF Vapor Ablation 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 2024-12-12 under 510(k) number K241271. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Aqua Medical RF Vapor Ablation System?

Aqua Medical RF Vapor Ablation System is a medical device that received FDA 510(k) clearance on 2024-12-12. The listed applicant is Aqua Medical, Inc.. The 510(k) number is K241271.

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

Aqua Medical RF Vapor Ablation System received FDA 510(k) clearance on 2024-12-12, under 510(k) number K241271.

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

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

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Aqua Medical, Inc. como solicitante

K251226Sistema de Ablación de Vapor RF Médico Aqua, Agua Médica K213627RF Vapor System K211282Sistema de Vapor RF Médico Aqua, Agua Médica K183595Sistema de Vapor RF Médico Aqua, Agua Médica

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

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.