Cleared Special

K110291 - NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE

K110291 is an FDA 510(k) clearance for NAVIAID ICVI-F DEVICE, manufactured by Smart Medical Systems , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code ODC cleared through the Special 510(k) pathway after a 136-day FDA review.

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

FDA 510(k) Submission Details - K110291

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 131d · This submission: 136d
Pathway characteristics
Modification to existing cleared device.

ODC Device Classification - Class 2, Special Controls

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 66
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