DeviceClearance

Product code QKZ— Gastroenterology, Urology

NaviCam Capsule Endoscope System with NaviCam Stomach Capsule

Classification name
Magnetically Maneuvered Capsule Endoscopy System
Device class
Class 2
Regulation
21 CFR 876.1310
Advisory panel
Gastroenterology, Urology
Total cleared
6
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QKZ under 21 CFR 876.1310, via openFDA

Market context for product code QKZ

FDA has cleared 6 devices under product code QKZ between 2020 and 2024, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QKZ

Recent clearances under product code QKZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.