Skip to content

Protege Self-expanding Nitinol Stent With Starport Delivery Technology

by Sulzer Intratherapeutics, Inc. 3 variants

510(k) K011806

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESU Traditional NumberK011806 Date7 Sep 2001ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0707-06 FDA Unclassified (pre-2012) initiated 27 Feb 2006

    Mispackaging-Protege GPS SER6-9-60-125 devices were incorrectly packaged as SER6-7-80-135. Diameter is larger than expected.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FGE
Device Class
Class II
Regulation
21 CFR Part 876.5010
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESU

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Protege Self-expanding Nitinol Stent with Starport Delivery Technology is a self-expanding nitinol stent intended as a palliative treatment of malignant neoplasms in the biliary tree. The stent is premounted on a 0.035" over-the-wire delivery catheter available in 80 or 120 cm lengths. The system includes an inner/outer sheath with safety lock, stent retainer, and contrast injection ports.

The stent is deployed via transhepatic access and exerts constant outward force. It is a single-use device and requires proper storage conditions. The device has received FDA 510(k) clearance with product code FGE and is classified under device class 2 for Stents, Drains And Dilators For The Biliary Ducts.

Other devices from Sulzer Intratherapeutics, Inc.

See all devices from Sulzer Intratherapeutics, Inc. →

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Protege Self-Expanding Nitinol Stent used for?

    The Protege Self-Expanding Nitinol Stent is intended as a palliative treatment for malignant neoplasms in the biliary tree. It is deployed via transhepatic access and exerts constant outward force to maintain bile duct patency.

  • How is the Protege Stent supplied and what is its delivery system?

    The stent is premounted on a 0.035" over-the-wire delivery catheter available in 80 or 120 cm lengths. The system includes an inner/outer sheath with safety lock, stent retainer, and contrast injection ports for precise deployment.

  • Is the Protege Stent single-use or reusable?

    The Protege Self-Expanding Nitinol Stent is a single-use device and should not be reused. It requires proper storage conditions as specified by the manufacturer to maintain its integrity and functionality.

  • What is the regulatory classification of the Protege Stent?

    The device has received FDA 510(k) clearance with product code FGE and is classified under device class 2 for Stents, Drains And Dilators For The Biliary Ducts. It was cleared through the traditional 510(k) pathway in 2001.