Skater Biliary Catheter

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

510(k) Number

K073672 ↗

FDA Product Code

FGE

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• What is the Skater Biliary Catheter used for?

  The Skater Biliary Catheter is designed for percutaneous biliary drainage, allowing access to the biliary system via the Seldinger technique to drain bile when natural flow is obstructed.

• What sizes and configurations are available for the Skater Biliary Catheter?

  The device is supplied in 8, 10, and 12 French sizes, each with a fixed length of 40 cm, and features a pigtail-loop, locking-type configuration with drainage holes and stiffening cannulas.

• Is the Skater Biliary Catheter sterile and intended for single use?

  While the device data does not explicitly state sterility or single-use status, as a percutaneous drainage catheter placed via the Seldinger technique, it is intended for sterile, single-use implantation to prevent infection and ensure patient safety.

• What materials and components make up the Skater Biliary Catheter?

  The catheter is constructed from polyurethane and includes a pigtail-loop design with drainage holes, metal or plastic stiffening cannulas for shape retention, and a standard luer locking hub for secure connection to drainage systems.

• How is the Skater Biliary Catheter inserted and secured in place?

  The device is inserted percutaneously using the Seldinger technique, and its locking-type pigtail-loop configuration helps maintain position within the biliary duct after deployment, reducing the risk of migration.