FDA 510(k)

Creo Electrosurgical System with HS1 Hemostasis Accessory

N.º K: K192905 · 2020-03-19

Fecha de decisión2020-03-19

Código de productoKNS

Comité asesorGU

DecisiónUnknown

Resumen del dispositivo

Creo Electrosurgical System with HS1 Hemostasis Accessory is the device name listed in this FDA 510(k) record. The listed applicant is Creo Medical, Ltd.. It received FDA 510(k) clearance on 2020-03-19 under 510(k) number K192905. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Preguntas frecuentes

What is the Creo Electrosurgical System with HS1 Hemostasis Accessory?

Creo Electrosurgical System with HS1 Hemostasis Accessory is a medical device that received FDA 510(k) clearance on 2020-03-19. The listed applicant is Creo Medical, Ltd.. The 510(k) number is K192905.

When did Creo Electrosurgical System with HS1 Hemostasis Accessory receive FDA 510(k) clearance?

Creo Electrosurgical System with HS1 Hemostasis Accessory received FDA 510(k) clearance on 2020-03-19, under 510(k) number K192905.

Who is the listed applicant for Creo Electrosurgical System with HS1 Hemostasis Accessory?

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

What is the FDA product code for Creo Electrosurgical System with HS1 Hemostasis Accessory?

The FDA product code for Creo Electrosurgical System with HS1 Hemostasis Accessory is KNS.

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Otros registros que enlistan a Creo Medical, Ltd. como solicitante

K242774SpydrBlade Flex Instrument (PRD-RG1-001)K242983CROMA Electrosurgical Generator (PRD-EMR-050)K242061Reusable Interface Cable 1.5 m (PRD-IFC-002)K230328Speedboat Flush SB1 Instrument K223138Instrumento Electrosurgical AB1, Sistema Electrosurgical Creo K221672Creo Electrosurgical System with NP1 Instrument

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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

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