Magnetically Maneuvered Capsule Endoscopy System
QKZ is the FDA product code for Magnetically Maneuvered Capsule Endoscopy System, a class II device type, regulated under 21 CFR 876.1310. FDA's definition for this code reads: "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...". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QKZ
- Device name
- Magnetically Maneuvered Capsule Endoscopy System
- FDA 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.
- Regulation
- 21 CFR 876.1310
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 6
- Ingested recalls
- 0
Clearances, product code QKZ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 1 |
Applicants with the most clearances
Product code QKZ| Applicant | Clearances |
|---|---|
| Anx Robotica Corp. | 6 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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