# K973114: Silicone Biliary Stent/Biliary Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Specialty Surgical Products, Inc.
- Decided: Sep 19, 1997 after 30 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Percutaneous biliary drainage with the Biliary Stent is utilized for the management of both benign and malignant biliary obstruction. The stent is used to prevent or relieve sepsis, to relieve symptoms of obstruction such as pruritis, and to maintain a pathway for bile flow into the bowel for digestive function. The stent is indicated for malignant biliary obstruction, such as primary bile duct or biliary tract carcinoma, pancreatic carcinoma, metastases to the porta hepatis, and other malignant conditions causing obstructive jaundice. The stent can also be used in cases of benign biliary obstruction such as strictures secondary to primary or iatrogenic trauma pancreatitis, biliary calculi, or biliary leaks.

Source page: https://510kreport.com/device/K973114
Methodology: https://510kreport.com/methodology