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510(k) K241934

NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether) by Anx Robotica Corp — Product Code QKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2024
Date Received
July 2, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Magnetically Maneuvered Capsule Endoscopy System
Device Class
Class II
Regulation Number
876.1310
Review Panel
GU
Submission Type

A magnetically maneuvered capsule endoscopy system consists of an ingestible capsule and magnetic controller and is used for visualization of the stomach and duodenum. The ingestible capsule contains a camera that wirelessly captures images of the mucosa. The magnetic controller is used outside of the patient and is magnetically coupled with the capsule to control its location and viewing direction.

Other clearances by Anx Robotica Corp

  • K230694 — NaviCam Xpress Stomach System, NaviCam Xpress System (April 13, 2023)
  • K221608 — NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether (November 22, 2022)
  • K203192 — NaviCam Xpress Stomach System (May 4, 2021)
  • DEN190037 — NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (May 22, 2020)
  • K201106 — IntraMarX 3D Radiopaque Marker (May 21, 2020)
  • K191087 — IntraMarX Radiopaque Markers (December 18, 2019)

Other clearances for product code QKZ

  • K231960 — NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) (October 3, 2023)
  • K230694 — NaviCam Xpress Stomach System, NaviCam Xpress System (April 13, 2023)
  • K221608 — NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether (November 22, 2022)
  • K203192 — NaviCam Xpress Stomach System (May 4, 2021)
  • DEN190037 — NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (May 22, 2020)