Cleared Traditional

K221608 - 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 (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221608 · Anx Robotica Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2022
Decision
172d
Days
Class 2
Risk

K221608 is an FDA 510(k) clearance for the NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tet.... 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 November 22, 2022 after a review of 172 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1310 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Anx Robotica Corp devices

Submission Details

510(k) Number K221608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2022
Decision Date November 22, 2022
Days to Decision 172 days
Submission Type Traditional
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
42d slower than avg
Panel avg: 130d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K221608.
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 Xpress Stomach System, NaviCam Xpress System
K230694 · Anx Robotica Corp · Apr 2023
NaviCam Xpress Stomach System
K203192 · Anx Robotica Corp · May 2021