QKZ · Class II · 21 CFR 876.1310

FDA Product Code QKZ: Magnetically Maneuvered Capsule Endoscopy System

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.

Leading manufacturers include Anx Robotica Corp, Anx Robotica Corporation and Anx Robotica, Inc..

6
Total
5
Cleared
133d
Avg days
2020
Since
Declining activity - 0 submissions in the last 2 years vs 4 in the prior period

FDA 510(k) Cleared Magnetically Maneuvered Capsule Endoscopy System Devices (Product Code QKZ)

6 devices
1–6 of 6
Cleared Jul 31, 2024
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)
K241934
Anx Robotica Corp
Gastroenterology & Urology · 29d
Cleared Oct 03, 2023
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether
K231960
Anx Robotica Corporation
Gastroenterology & Urology · 92d
Cleared Apr 13, 2023
NaviCam Xpress Stomach System, NaviCam Xpress System
K230694
Anx Robotica Corp
Gastroenterology & Urology · 31d
Cleared Nov 22, 2022
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
K221608
Anx Robotica Corp
Gastroenterology & Urology · 172d
Cleared May 04, 2021
NaviCam Xpress Stomach System
K203192
Anx Robotica Corp
Gastroenterology & Urology · 188d
Not Cleared May 22, 2020
NaviCam Capsule Endoscope System with NaviCam Stomach Capsule
DEN190037
Anx Robotica, Inc.
Gastroenterology & Urology · 283d

About Product Code QKZ - Regulatory Context

510(k) Submission Activity

6 total 510(k) submissions under product code QKZ since 2020, with 5 receiving FDA clearance (average review time: 133 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 4 in the prior period.