# K903842: ST-E1 Overtube

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Corp.
- Decided: Jan 23, 1991 after 155 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
No predicates in its family tree.
22 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K023902: Shape-Lockable Endoscopic Overtube (2003), 17 descendants of its own
- 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

Source page: https://510kreport.com/device/K903842
Methodology: https://510kreport.com/methodology