# K032025: Sentinol Nitinol Billary Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Sep 25, 2003 after 87 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices 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) Boston Scientific Wallstent Biliary Endoprosthesis with Unistep Plus RP Delivery System: named in the summary without a submission number
- (no number) Cordis S.M.A.R.T.TM Nitinol Stent Transhepatic Biliary System: named in the summary without a submission number
- (no number) Guidant DYNALINKTM Biliary Self-Expanding Stent System: named in the summary without a submission number

## Most influential descendants
- K072301: 5MM Protege Everflex Self Expanding Biliary Stent System, Model PRP35-05 (2008), 2 descendants of its own
- K262913: Protégé™ EverFlex™ Self-expanding Peripheral Stent System (2026), 0 descendants of its own
- K111627: Supera Veritas (R) Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System (2012), 0 descendants of its own

## Recalls of this device
- May 14, 2004 · Not classified · Z-0440-06: One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. The product, pouch label and carton label are all correct

## Indications for use
The Boston Boston Scientific SentinolTMNitinol Biliary Stent System is indicated for palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K032025
Methodology: https://510kreport.com/methodology