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GUIDANCE DOCUMENT

Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions Guidance for Industry and Food and Drug Administration Staff July 2018

Draft

Not for implementation. Contains non-binding recommendations.

Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions

Docket Number:
FDA-2018-D-1771
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This draft guidance document provides draft recommendations for 510(k) submissions for metal expandable biliary stents and their associated delivery systems. These devices are intended to provide luminal patency of the biliary tree. This guidance is issued for comment purposes only.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-1771.