FDA 510(k)

NaviCam Xpress Stomach System, NaviCam Xpress System

N.º K: K230694 · 2023-04-13

Fecha de decisión2023-04-13

Código de productoQKZ

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

NaviCam Xpress Stomach System, NaviCam Xpress System is the device name listed in this FDA 510(k) record. The listed applicant is Anx Robotica Corp. It received FDA 510(k) clearance on 2023-04-13 under 510(k) number K230694. The device is classified under product code QKZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the NaviCam Xpress Stomach System, NaviCam Xpress System?

NaviCam Xpress Stomach System, NaviCam Xpress System is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is Anx Robotica Corp. The 510(k) number is K230694.

When did NaviCam Xpress Stomach System, NaviCam Xpress System receive FDA 510(k) clearance?

NaviCam Xpress Stomach System, NaviCam Xpress System received FDA 510(k) clearance on 2023-04-13, under 510(k) number K230694.

Who is the listed applicant for NaviCam Xpress Stomach System, NaviCam Xpress System?

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

What is the FDA product code for NaviCam Xpress Stomach System, NaviCam Xpress System?

The FDA product code for NaviCam Xpress Stomach System, NaviCam Xpress System is QKZ.

Ensayos clínicos relacionados

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Otros registros que enlistan a Anx Robotica Corp como solicitante

K241934NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)K221608NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether K203192NaviCam Xpress Stomach System K201106IntraMarX 3D Radiopaque Marker K191087IntraMarX Radiopaque Markers

Dispositivos relacionados (Código: QKZ)

Fuente oficial

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