# K103478: Single Use Biliary Drainage Stent V

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Feb 24, 2011 after 90 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- 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 K933200 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933200: Olympus PBD Stents, Olympus Corp. (1995) Summary page 2.

## Indications for use
This instrument has been designed to be used with Olympus Endoscopes for endoscopic retrograde biliary drainage (ERBD). The stent is not intended to be permanently implanted in the patient. The stent is intended only for short-term implantation.

Source page: https://510kreport.com/device/K103478
Methodology: https://510kreport.com/methodology