# K091759: Single Use Splinting Tube, Models ST-Y0002-S, ST-Y0002-H, ST-Y0003-S and ST-Y0003-H

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Sep 18, 2009 after 94 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K853585 (1986). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071254: Small Intestinal Videoscope System, Olympus Medical Systems Corporation (2008) Summary page 3.

## Indications for use
This instrument has been designed to be used with the VIDEOSCOPE XCHF-T160 for endoscopy and endoscopic surgery within the biliary tract.

Source page: https://510kreport.com/device/K091759
Methodology: https://510kreport.com/methodology