# K112106: Naviaid Icvi-F,S,B,R Device

- Pathway: 510(k) (Traditional)
- Applicant: Smart Medical Systems, Ltd.
- Decided: Feb 6, 2012 after 199 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: 2 generations back to K101191 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

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

## Indications for use
The NaviAidTM ICVI device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope in the small intestine (i.e., an endoscope that is used for standard intestinal endoscopic visualization and has a compatible instrument channel as defined in the instructions for use)

Source page: https://510kreport.com/device/K112106
Methodology: https://510kreport.com/methodology