# K102616: Naviaid Balloon Guided Colonoscopy (BGC) Device

- Pathway: 510(k) (Traditional)
- Applicant: Smart Medical Systems, Ltd.
- Decided: Dec 30, 2010 after 111 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- 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: 3 generations back to K993704 (2000). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 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)
- K090116: Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15, Fujinon, Inc. (2009) Summary page 2.

## Most influential descendants
- K111760: Naviaid (TM) BGC Device (2011), 1 descendant of its own
- K232327: Endorail (2024), 0 descendants of its own

## Indications for use
The NaviAidTm BUC 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 3.7mmn diameter and is used for standard endoscopic visualization).

Source page: https://510kreport.com/device/K102616
Methodology: https://510kreport.com/methodology