Cleared Special

NaviCam Xpress Stomach System, NaviCam Xpress System

K230694 · Anx Robotica Corp · Gastroenterology & Urology

Apr 2023

Decision

31d

Days

Class 2

Risk

About This 510(k) Submission

K230694 is an FDA 510(k) clearance for the NaviCam Xpress Stomach System, NaviCam Xpress System, a Magnetically Maneuvered Capsule Endoscopy System (Class II — Special Controls, product code QKZ), submitted by Anx Robotica Corp (Plano, US). The FDA issued a Cleared decision on April 13, 2023, 31 days after receiving the submission on March 13, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1310.

Submission Details

510(k) Number	K230694 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 13, 2023
Decision Date	April 13, 2023
Days to Decision	31 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	QKZ — Magnetically Maneuvered Capsule Endoscopy System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1310
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.