FDA.reportPublic FDA data

ANX ROBOTICA CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30165442483016544248ANX ROBOTICA CORP.1Y2026-01-016010 W. Spring Creek Pkwy Plano TX US 75024

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2378421499543621K250493MotiliCap GI Monitoring SystemNYV2025-05-21
2378421786266155K241934NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)QKZ2024-07-31
2378421775512655K233229NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam TetherNEZ2024-01-05
2378421942587578K231960NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam TetherQKZ2023-10-03
2378421558198044K230694NaviCam Xpress Stomach System, NaviCam Xpress SystemQKZ2023-04-13
2378421773563426K221608NaviCam 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 TetherQKZ2022-11-22
2378421847449762K221590NaviCam Small Bowel Capsule Endoscopy SystemNEZ2022-12-02
2378421668574504K203192NaviCam Xpress Stomach SystemQKZ2021-05-04
2378421129486182K201106IntraMarX 3D Radiopaque MarkerFFX2020-05-21
2378421798102525K191087IntraMarX Radiopaque MarkersFFX2019-12-18
2378422030555774DEN230027NaviCam ProScanQZF2023-12-12
2378421342276045DEN190037NaviCam Capsule Endoscope System with NaviCam Stomach CapsuleQKZ2020-05-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QKZ62024-07-31
NEZ22024-01-05
FFX22020-05-21
NYV12025-05-21
QZF12023-12-12

PMN#