# K023243: Modification to Protege Self-Expanding Nitinol Stent with Starport Delivery Technology

- Pathway: 510(k) (Special)
- Applicant: Sulzer Intratherapeutics, Inc.
- Decided: Dec 13, 2002 after 74 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.
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) Protégé Self-expanding Nitinol Stent with StarPort Delivery Technology: named in the summary without a submission number

## Recalls of this device
- Apr 15, 2003 · Not classified · Z-0863-03: The label had an expiration date of August 2005, but the correct expiration date was February 2005.

## Indications for use
The ProtegFM Self-expanding Nitinol Stent with StarPortTM Delivery Technology is intended as a palliative treatment of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K023243
Methodology: https://510kreport.com/methodology