Cleared Special

K230694 - NaviCam Xpress Stomach System, NaviCam Xpress System (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K230694 · Anx Robotica Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
31d
Days
Class 2
Risk

K230694 is an FDA 510(k) clearance for the NaviCam Xpress Stomach System, NaviCam Xpress System. Classified as Magnetically Maneuvered Capsule Endoscopy System (product code QKZ), Class II - Special Controls.

Submitted by Anx Robotica Corp (Plano, US). The FDA issued a Cleared decision on April 13, 2023 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1310 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Anx Robotica Corp devices

Submission Details

510(k) Number K230694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 130d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QKZ Magnetically Maneuvered Capsule Endoscopy System
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - QKZ Magnetically Maneuvered Capsule Endoscopy System

Devices cleared under the same product code (QKZ) and FDA review panel - the closest regulatory comparables to K230694.
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)
K241934 · Anx Robotica Corp · Jul 2024
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether
K231960 · Anx Robotica Corporation · Oct 2023
NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether
K221608 · Anx Robotica Corp · Nov 2022
NaviCam Xpress Stomach System
K203192 · Anx Robotica Corp · May 2021