# K092352: Scuba Biliary Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Invatec S.P.A.
- Decided: Mar 16, 2010 after 224 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: 8 generations back to K905720 (1991). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012590: Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery System, Cordis Corp. (2001) Summary page 1.
- K033394: Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035 Delivery System, Cordis Corp. (2003) Summary page 1.
- K032768: Medtronic, Inc. Racer Biliary Stent System (Racer), Model XD#YF (L), Medtronic Ave, Inc. (2003) Summary page 1.

## Indications for use
SCUBA Biliary Stent System is indicated for the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K092352
Methodology: https://510kreport.com/methodology