# K021729: Modification to Protege Self-Expanding Nitinol Stent with Starport Delivery Technology

- Pathway: 510(k) (Special)
- Applicant: Sulzer Intratherapeutics, Inc.
- Decided: Jun 21, 2002 after 28 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
Longest line of descent: 2 generations back to K003040 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012066: Protege Self-Expanding Nitinol Stent with Starport Delivery Technology, Sulzer Intratherapeutics, Inc. (2001)

## Indications for use
The Prot6g6TMSelf-ExpandingNitinol Stent with StarPortTMDelivery Technology (Biliary Indication) is intended as a palliative treatment of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K021729
Methodology: https://510kreport.com/methodology