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FDA 510(k)

NaviCam 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

Número K: K221608 · 2022-11-22

RequerenteAnx Robotica Corp
Data da decisão2022-11-22
Código do produtoQKZ
Comité consultivoGU
DecisãoSubstantially Equivalent

Resumo do dispositivo

NaviCam 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 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 2022-11-22 under 510(k) number K221608. The device is classified under product code QKZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NaviCam 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?

NaviCam 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 is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is Anx Robotica Corp. The 510(k) number is K221608.

When did NaviCam 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 receive FDA 510(k) clearance?

NaviCam 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 received FDA 510(k) clearance on 2022-11-22, under 510(k) number K221608.

Who is the listed applicant for NaviCam 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?

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 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?

The FDA product code for NaviCam 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 is QKZ.

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Outros registros que listam Anx Robotica Corp como candidato(a)

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K241934NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)K230694NaviCam Xpress Stomach System, NaviCam Xpress SystemK203192NaviCam Xpress Stomach SystemK201106IntraMarX 3D Radiopaque MarkerK191087IntraMarX Radiopaque Markers

Dispositivos Relacionados (Código: QKZ)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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 CorpK231960NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam TetherAnx Robotica CorporationK230694NaviCam Xpress Stomach System, NaviCam Xpress SystemAnx Robotica CorpK203192NaviCam Xpress Stomach SystemAnx Robotica Corp

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