FDA Product Code QKZ: Magnetically Maneuvered Capsule Endoscopy System
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.
Leading manufacturers include Anx Robotica Corp and Anx Robotica Corporation.
FDA 510(k) Cleared Magnetically Maneuvered Capsule Endoscopy System Devices (Product Code QKZ)
About Product Code QKZ - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code QKZ since 2020, with 5 receiving FDA clearance (average review time: 133 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under QKZ have taken an average of 29 days to reach a decision - down from 153 days historically, suggesting improved FDA processing for this classification.
QKZ devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →