# K011806: Protege Self-Expanding Nitinol Stent with Starport Delivery Technology

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Intratherapeutics, Inc.
- Decided: Sep 7, 2001 after 88 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
Longest line of descent: 1 generation back to K003040 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003040: Intrastent Protege Self-Expanding Nitinol Stent with Starport Delivery Technology, Intratherapeutics, Inc. (2000) Summary page 1.

## Recalls of this device
- Feb 27, 2006 · Not classified · Z-0707-06: Mispackaging-Protege GPS SER6-9-60-125 devices were incorrectly packaged as SER6-7-80-135. Diameter is larger than expected.

## Indications for use
The Protégé™ Self-Expanding Nitinol Stent with StarPort™ Delivery Technology (Biliary Indication) is intended as a palliative treatment of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K011806
Methodology: https://510kreport.com/methodology