# K070622: Neoguide Endoscopy System

- Pathway: 510(k) (Traditional)
- Applicant: Neoguide Systems, Inc.
- Decided: Aug 14, 2007 after 161 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: 6 generations back to K921244 (1992). 29 ancestors in all.
12 later devices descend from it; 4 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052930: Navigator Endoscopy System, Neoguide Systems, Inc. (2006) Summary page 1.
- K001241: Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I, The Olympus Optical Co. (2000)
- K961563: EC-384OTL, Video Colonscope, Pentax Precision Instrument Corp. (1996) Summary page 1.
- K032688: Colonosight Model 510B, Sightline Technologies, Ltd. (2004) Summary page 1.
- K033954: Shape Locking Endoscopic Overtube, Usgi Medical, Inc. (2004) Summary page 1.

## Most influential descendants
- K100624: Invendo C20 Colonoscopy System (2012), 6 descendants of its own
- K121582: Invendo C25 Colonoscopy System (2012), 5 descendants of its own
- K141286: Aer-O-Scope Colonoscope System (2014), 2 descendants of its own
- K162330: Flex Robotic System and Flex Colorectal Drive (2017), 1 descendant of its own
- K161355: invendoscopy E200 System (2016), 1 descendant of its own

## Indications for use
The NeoGuide Endoscopy System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including, but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery.

Source page: https://510kreport.com/device/K070622
Methodology: https://510kreport.com/methodology