# K060923: Naviaid Bge Device, Model 21-001

- Pathway: 510(k) (Traditional)
- Applicant: Smart Medical Systems, Ltd.
- Decided: Aug 15, 2006 after 133 days
- Product code: FDA (Enteroscope And Accessories)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K993704 (2000). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040048: Fujinon Double Balloon Enteroscopy System, Fujinon, Inc. (2004) Summary page 2.

## Most influential descendants
- K110531: Endoflip Ecd (2011), 1 descendant of its own
- K150083: Sidecar External Working Channel (2015), 0 descendants of its own

## Indications for use
The NaviAidTM BGE device is an accessory to an endoscope and is intended to ensure complete positioning of a standard endoscope in the small intestine (i.e., an endoscope that is 10-13 mm in diameter and is used for standard intestinal endoscopic visualization).

Source page: https://510kreport.com/device/K060923
Methodology: https://510kreport.com/methodology