FDA product code QKZ

Magnetically Maneuvered Capsule Endoscopy System

Gastroenterology, Urology·Class 2·21 CFR 876.1310
US regulatory classifications
US Product Code (FDA)
QKZ
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 876.1310
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Medical specialty
Gastroenterology, Urology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Magnetically Maneuvered Capsule Endoscopy System is a medical device type in the Gastroenterology, Urology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.