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Naviaid Icvi-F Device, Naviaid Icvi-S Device, Naviaid Icvi-B Device

FDA 510(k)

Class II (US FDA 510(k))

510(k) K110291

by Smart Medical Systems Ltd

Identifiers

510(k) Number
K110291 FDA 510(k)
FDA Product Code
ODC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Naviaid ICVI-F Device, Naviaid ICVI-S Device, and Naviaid ICVI-B Device are endoscope channel accessories. They are substantially equivalent to predicate devices and were cleared via the FDA 510(k) process under product code ODC and regulation number 876.1500.

These devices are intended to facilitate penetration of standard endoscopes into the small intestine while maintaining endoscopic advantages such as navigation, stopping propagation if needed, real-time operation, video imaging, and instrument channel use. They are supplied as accessories for use with endoscopes in gastroenterology and urology procedures.

Frequently asked questions

What is the Naviaid ICVI-F, ICVI-S, and ICVI-B device used for?

These devices are endoscope channel accessories intended to facilitate penetration of standard endoscopes into the small intestine while maintaining endoscopic advantages such as navigation, real-time operation, video imaging, and instrument channel use during gastroenterology and urology procedures.

How are the Naviaid ICVI-F, ICVI-S, and ICVI-B devices supplied?

The devices are supplied as accessories for use with endoscopes in gastroenterology and urology procedures, as stated in the device description.

What regulatory pathway was used for the Naviaid ICVI-F, ICVI-S, and ICVI-B devices?

The devices were cleared via the FDA 510(k) process under product code ODC and regulation number 876.1500, as they are substantially equivalent to predicate devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Naviaid Icvi-f Device, Naviaid Icvi-s Device, Naviaid Icvi-b Device ..., NAVIAID ICVI-F,S,B,R DEVICE (K112106) — FDA 510(k) | Innolitics, NaviAid™ AB - Smart Medical Systems

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Smart Medical Systems Ltd
FDA Applicant
Smart Medical Systems , Ltd.

Sources (1)

  • FDA 510(k) K110291 24 fields · synced Oct 6, 2026