Cleared Special

K110291 - NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE (FDA 510(k) Clearance)

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

K110291 · Smart Medical Systems , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
136d
Days
Class 2
Risk

K110291 is an FDA 510(k) clearance for the NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE. Classified as Endoscope Channel Accessory (product code ODC), Class II - Special Controls.

Submitted by Smart Medical Systems , Ltd. (Raanana, IL). The FDA issued a Cleared decision on June 17, 2011 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Smart Medical Systems , Ltd. devices

Submission Details

510(k) Number K110291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2011
Decision Date June 17, 2011
Days to Decision 136 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 130d · This submission: 136d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ODC Endoscope Channel Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Give The Endoscope Channel Additional Or Improved Functionality.
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 - ODC Endoscope Channel Accessory

All 70
Devices cleared under the same product code (ODC) and FDA review panel - the closest regulatory comparables to K110291.
Biopsy Port Adapter
K250145 · Endosound, Inc. · Oct 2025
Orca Air/Water and Suction Valves
K252910 · Boston Scientific · Oct 2025
Suction Valve (MAJ-1443)
K250949 · Olympus Medical Systems Corporation · Jul 2025
Disposable Endoscopy Valve Set
K250732 · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Jun 2025
Luer-Split MAJ-2092
K241842 · Olympus Medical Systems Corporation · Mar 2025
Defendo Fujifilm 700 Single Use Cleaning Adapter
K250140 · Steris Corparation · Feb 2025