FDA 510(k)

NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether

N.º K: K231960 · 2023-10-03

Fecha de decisión2023-10-03

Código de productoQKZ

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether is the device name listed in this FDA 510(k) record. The listed applicant is Anx Robotica Corporation. It received FDA 510(k) clearance on 2023-10-03 under 510(k) number K231960. 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 Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether?

NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether is a medical device that received FDA 510(k) clearance on 2023-10-03. The listed applicant is Anx Robotica Corporation. The 510(k) number is K231960.

When did NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether receive FDA 510(k) clearance?

NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether received FDA 510(k) clearance on 2023-10-03, under 510(k) number K231960.

Who is the listed applicant for NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether?

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

What is the FDA product code for NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether?

The FDA product code for NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether is QKZ.

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Otros registros que enlistan a Anx Robotica Corporation como solicitante

K250493MotiliCap GI Monitoring System K233229NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether

Dispositivos relacionados (Código: QKZ)

K241934NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)Anx Robotica Corp K230694NaviCam Xpress Stomach System, NaviCam Xpress SystemAnx Robotica Corp 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 TetherAnx Robotica Corp K203192NaviCam Xpress Stomach SystemAnx Robotica Corp

Fuente oficial

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