Cleared Special

K111760 - NAVIAID(TM) BGC DEVICE

K111760 is an FDA 510(k) clearance for NAVIAID(TM) BGC 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 48-day FDA review.

K111760 · Smart Medical Systems , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
48d
Days
Class 2
Risk

K111760 is an FDA 510(k) clearance for the NAVIAID(TM) BGC 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 August 9, 2011 after a review of 48 days - a notably fast clearance cycle.

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. 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 Smart Medical Systems , Ltd. devices

FDA 510(k) Submission Details - K111760

510(k) Number K111760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2011
Decision Date August 09, 2011
Days to Decision 48 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
82d faster than avg
Panel avg: 130d · This submission: 48d
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 51
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