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# Biliary Stent 510(k) Submission Guidance
- URL: https://www.fdaweb.com/biliary-stent-510-k-submission-guidance/
- Published: 2018-07-17T12:00:00.000Z
- Updated: 2026-09-15T00:19:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141893

FDA has published a draft guidance, *Metal Expandable Biliary Stents-Premarket Notification (510(k) Submissions*, to receive stakeholder comments on draft recommendations for 510(k) submissions for metal expandable biliary stents and their associated delivery systems. The [document](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM613478.pdf?ref=fdaweb.com) says devices are intended to provide luminal patency of the biliary tree.

When finalized, the draft will supersede a 2/5/98 guidance by updating it to reflect current review practices.

The guidance applies only to biliary stents indicated for palliation of malignant strictures in the biliary tree. It does not apply to biliary stents intended to treat benign structures or stents intended to be used in the vasculature, tracheal/bronchial tubes, or other gastrointestinal anatomy.