# K973171: Nir Biliary Stent

- Pathway: 510(k) (Traditional)
- Applicant: Medinol, Ltd.
- Decided: Nov 13, 1998 after 445 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. The FDA summary names its predicate without a number.
- (no number) Johnson & Johnson Palmaz™ Biliary Stent: named in the summary without a submission number
- (no number) BSC Symphony™ Transhepatic Biliary Stent System: named in the summary without a submission number

## Indications for use
The NIR Biliary Stent is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.

Source page: https://510kreport.com/device/K973171
Methodology: https://510kreport.com/methodology