# K063654: Endoguide

- Pathway: 510(k) (Traditional)
- Applicant: Kms Medical, LLC
- Decided: Jan 31, 2007 after 54 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: 1 generation back to K040836 (2004). 1 ancestor in all.
7 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040836: Disposable Overtube, United States Endoscopy Group, Inc. (2004) Summary page 1.

## Most influential descendants
- K191415: Pathfinder Endoscope Overtube (2019), 6 descendants of its own
- K211301: Pathfinder Endoscope Overtube (2021), 3 descendants of its own
- K230752: Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) (2023), 1 descendant of its own
- K262262: Pathfinder Endoscope Overtube (2026), 0 descendants of its own
- K243091: Over-tube (TR-1108A) (2024), 0 descendants of its own

## Indications for use
The EndoGuide is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and removal of multiple polyps and/or foreign bodies.

Source page: https://510kreport.com/device/K063654
Methodology: https://510kreport.com/methodology