# K110291: Naviaid Icvi-F Device, Naviaid Icvi-S Device, Naviaid Icvi-B Device

- Pathway: 510(k) (Special)
- Applicant: Smart Medical Systems, Ltd.
- Decided: Jun 17, 2011 after 136 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: 1 generation back to K101191 (2010). 1 ancestor in all.
3 later devices descend from it; 2 cite 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)
- K101191: Naviaid Icvi Device, Smart Medical Systems, Ltd. (2010)

## Most influential descendants
- K111760: Naviaid (TM) BGC Device (2011), 1 descendant of its own
- K232327: Endorail (2024), 0 descendants of its own
- K112106: Naviaid Icvi-F,S,B,R Device (2012), 0 descendants of its own

## Indications for use
The NaviAidTM ICVT 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 has an instrument channel that is at least 3.7mm and is used for standard intestinal endoscopic visualization).

Source page: https://510kreport.com/device/K110291
Methodology: https://510kreport.com/methodology