# K971125: Endo Smartcap (100501)

- Pathway: 510(k) (Traditional)
- Applicant: Endo Smart Cap Co.
- Decided: May 23, 1997 after 57 days
- Product code: OCX (Endoscopic Irrigation/Suction System)
- 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.
67 later devices descend from it; 3 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Olympus Model Number MD-431 Water Container: named in the summary without a submission number

## Most influential descendants
- K031773: Endo Gator System (2003), 58 descendants of its own
- K092429: Endogator (2009), 41 descendants of its own
- K093665: Endo Smartcap (2009), 18 descendants of its own
- K091305: Clearpath (2009), 13 descendants of its own
- K093779: Clearpath Ugi (2010), 10 descendants of its own

## Indications for use
The Endo SmartCap™ is intended to supply sterile water to series 10, 100 and 130 Olympus endoscopes when connected to a commercially available sterile water bottle.

Source page: https://510kreport.com/device/K971125
Methodology: https://510kreport.com/methodology