Product code QKZ

Device name

Magnetically Maneuvered Capsule Endoscopy System

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.1310

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset