# K111760: Naviaid (TM) BGC Device

- Pathway: 510(k) (Special)
- Applicant: Smart Medical Systems, Ltd.
- Decided: Aug 9, 2011 after 48 days
- Product code: ODC (Endoscope Channel Accessory)
- 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: 4 generations back to K993704 (2000). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102616: Naviaid Balloon Guided Colonoscopy (BGC) Device, Smart Medical Systems, Ltd. (2010) Summary page 2.
- K110291: Naviaid Icvi-F Device, Naviaid Icvi-S Device, Naviaid Icvi-B Device, Smart Medical Systems, Ltd. (2011) Summary page 3.

## Most influential descendants
- K232327: Endorail (2024), 0 descendants of its own

## Indications for use
The NaviAidTm BGC device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope during endoscopy of the small and large intestine (standard endoscope-i.e., an endoscope that has an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization).

Source page: https://510kreport.com/device/K111760
Methodology: https://510kreport.com/methodology