R Stent Biliary Endoprosthesis

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K010107 ↗

FDA Product Code

FGE

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESU

• Lifestent LP Sds Biliary Endoprosthesis

  Class II

  FDA 510(k) K023248 Active Cleared 11 Feb 2003

• Lifestent Sds Biliary Endoprosthesis, Lifestent Xl Sds Biliary Endoprosthesis

  Class II

  FDA 510(k) K023308 Active Cleared 14 Apr 2003

• Lifestent Biliary Endoprosthesis

  Class II

  FDA 510(k) K023121 Active Cleared 10 Mar 2003

• Lifestent Sds Biliary Endoprosthesis

  Class II

  FDA 510(k) K033212 Active Cleared 30 Oct 2003

• Lifestent Sds and Xl Sds Biliary Endoprosthesis

  Class II

  FDA 510(k) K040550 Active Cleared 16 Mar 2004

• Modification to Lifestent Sds and Xl Sds Biliary Endoprosthesis

  Class II

  FDA 510(k) K041032 Active Cleared 10 May 2004

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• What is the R Stent Biliary Endoprosthesis used for?

  The R Stent Biliary Endoprosthesis is designed to maintain patency in major bile ducts obstructed by malignant tissue. It is intended for permanent implantation to relieve biliary obstruction caused by tumors, ensuring continued bile flow in patients with malignant strictures.

• How is the R Stent Biliary Endoprosthesis supplied and prepared for use?

  The device is supplied as a single-use, sterile product. It is delivered via a percutaneous transluminal angioplasty (PTA) balloon catheter system, meaning it requires expansion within the bile duct using the balloon catheter before use. Follow standard sterile medical device handling procedures to ensure proper preparation.

• Is the R Stent Biliary Endoprosthesis reusable or intended for single-use?

  The R Stent Biliary Endoprosthesis is explicitly labeled as a single-use device. It is not designed for reuse, and adherence to single-use guidelines is critical to maintain sterility and patient safety.

• What storage conditions should be followed for the R Stent Biliary Endoprosthesis?

  While specific storage instructions are not detailed in the provided data, standard sterile medical device storage practices should be followed. This includes keeping the device in its original packaging, in a clean, dry environment, and away from direct sunlight or extreme temperatures until ready for use.

• What regulatory clearance does the R Stent Biliary Endoprosthesis hold?

  The R Stent Biliary Endoprosthesis is regulated under FDA 510(k) clearance with the clearance number K010107. This indicates that it has been deemed substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness.