FDA 510(k)

da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30

Número K: K191736 · 2019-07-26

Data da decisão2019-07-26

Código do produtoNAY

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 is the device name listed in this FDA 510(k) record. The listed applicant is Intuitive Surgical. It received FDA 510(k) clearance on 2019-07-26 under 510(k) number K191736. The device is classified under product code NAY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30?

da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 is a medical device that received FDA 510(k) clearance on 2019-07-26. The listed applicant is Intuitive Surgical. The 510(k) number is K191736.

When did da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 receive FDA 510(k) clearance?

da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 received FDA 510(k) clearance on 2019-07-26, under 510(k) number K191736.

Who is the listed applicant for da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30?

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

What is the FDA product code for da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30?

The FDA product code for da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 is NAY.

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Outros registros que listam Intuitive Surgical como candidato(a)

K260695da Vinci Firefly Imaging System K241635da Vinci E-200 Electrosurgical Generator K241621Da Vinci Monopolar and Bipolar Adapters (378896)K240723da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)K231212da Vinci E-200 Electrosurgical Generator K223039da Vinci E-200 Electrosurgical Generator

Ver todos os 14 dispositivos →

Dispositivos Relacionados (Código: NAY)

K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.K260695da Vinci Firefly Imaging SystemIntuitive Surgical K254192Senhance Ultrasonic SystemAsensus Surgical K253986Instrumentos de Feedback de Força da VinciIntuitive Surgical, Inc.K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.

Fonte oficial

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