Cleared Traditional

K060923 - NAVIAID BGE DEVICE

K060923 is an FDA 510(k) clearance for NAVIAID BGE DEVICE, manufactured by Smart Medical Systems , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FDA cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K060923 · Smart Medical Systems , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
133d
Days
Class 2
Risk

K060923 is an FDA 510(k) clearance for the NAVIAID BGE DEVICE, MODEL 21-001. Classified as Enteroscope And Accessories (product code FDA), Class II - Special Controls.

Submitted by Smart Medical Systems , Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on August 15, 2006 after a review of 133 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. 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 Smart Medical Systems , Ltd. devices

FDA 510(k) Submission Details - K060923

510(k) Number K060923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2006
Decision Date August 15, 2006
Days to Decision 133 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 130d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FDA Device Classification - Class 2, Special Controls

Product Code FDA Enteroscope And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Provide Visualization And Perform Various Procedures Within The Small Intestine. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - FDA Enteroscope And Accessories

All 15
Devices cleared under the same product code (FDA) and FDA review panel - the closest regulatory comparables to K060923.
FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5
K183683 · Fujifilm Corporation · Feb 2019
Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T
K143556 · Fujifilm Medical Systems U.S.A, Inc. · Aug 2015
SMALL INTESTINAL VIDEOSCOPE SYSTEM
K071254 · Olympus Medical Systems Corporation · Mar 2008
FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM
K040048 · Fujinon, Inc. · Jun 2004
GASTRO-INTESTINAL SYSTEM EN-410WM
K993704 · Fujinon, Inc. · Feb 2000
SIF-SW
K904800 · Olympus Corp. · Mar 1991