# K023902: Shape-Lockable Endoscopic Overtube

- Pathway: 510(k) (Traditional)
- Applicant: Usgi Medical, Inc.
- Decided: Aug 20, 2003 after 271 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- 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 K942044 (1994). 4 ancestors in all.
17 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903842: ST-E1 Overtube, Olympus Corp. (1991) Summary page 4.
- K973500: Bard Endoscopic Overtube (#000307), C.R. Bard, Inc. (1997) Summary page 4.
- K002018: Ndo Surgical Surgical Overtube, Surgical, Inc. (2000) Summary page 4.

## Most influential descendants
- K033954: Shape Locking Endoscopic Overtube (2004), 16 descendants of its own
- K052930: Navigator Endoscopy System (2006), 13 descendants of its own
- K070622: Neoguide Endoscopy System (2007), 12 descendants of its own
- K100624: Invendo C20 Colonoscopy System (2012), 6 descendants of its own
- K121582: Invendo C25 Colonoscopy System (2012), 5 descendants of its own

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

Source page: https://510kreport.com/device/K023902
Methodology: https://510kreport.com/methodology