FDA product code QKZ: Magnetically Maneuvered Capsule Endoscopy System
QKZ is the FDA product code for magnetically maneuvered capsule endoscopy system. It is a Class II device, regulated under 21 CFR 876.1310 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 5 510(k) submissions under QKZ, 4 in the last five years, from 2 different applicants. The average 510(k) review took 102 days (median 92); 29 days on average over the last three years. 1 De Novo request was granted under it.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Magnetically Maneuvered Capsule Endoscopy System |
| Device class | Class II |
| Regulation | 21 CFR 876.1310 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for QKZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 188 |
| 2022 | 1 | 172 |
| 2023 | 2 | 62 |
| 2024 | 1 | 29 |
Compare with all 510(k) review times · Search every QKZ clearance
Top QKZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Anx Robotica Corp | 4 | 2024-07-31 |
| Anx Robotica Corporation | 1 | 2023-10-03 |
Most recent QKZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241934 | Anx Robotica Corp | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether) | 2024-07-31 | 29 |
| K231960 | Anx Robotica Corporation | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether | 2023-10-03 | 92 |
| K230694 | Anx Robotica Corp | NaviCam Xpress Stomach System, NaviCam Xpress System | 2023-04-13 | 31 |
| K221608 | Anx Robotica Corp | 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 | 2022-11-22 | 172 |
| K203192 | Anx Robotica Corp | NaviCam Xpress Stomach System | 2021-05-04 | 188 |
Recalls for QKZ devices
openFDA lists no recalls for product code QKZ.
Frequently asked questions
What is FDA product code QKZ?
QKZ is the FDA product code for magnetically maneuvered capsule endoscopy system. It is a Class II device, regulated under 21 CFR 876.1310 and reviewed by the Gastroenterology and Urology panel.
What device class is QKZ?
Class II, regulation 21 CFR 876.1310. Typical premarket route: 510(k).
How long does a 510(k) take for product code QKZ?
Across 5 cleared submissions the average was 102 days from receipt to decision (median 92).
Which companies have the most QKZ clearances?
Anx Robotica Corp (4); Anx Robotica Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QKZ
- Run a recall and safety report across every QKZ manufacturer
- Watch product code QKZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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