# K965147: Biliary Stent, Biliary Stent System, Biliary Endoprosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jun 30, 1997 after 189 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 23 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K834468 (1984). 2 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K834468: Drainage Stent, Microvasive (1984) Summary page 3.
- K944290: Catheters, Biliary Catheters, Urological, Boston Scientific Corp (1994) Summary page 3.

## Most influential descendants
- K101314: Advanix Biliary Stent with Naviflex RX Delivery System (2010), 14 descendants of its own
- K133700: Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery System and Pushers (2014), 4 descendants of its own
- K193600: EndoGI Biliary Stent System (2020), 3 descendants of its own
- K140630: Wallflex Biliary RX Stent System (2014), 3 descendants of its own
- K202477: EndoGI S-Path Biliary Stent System (2020), 2 descendants of its own

## Recalls of this device
- Dec 26, 2018 · Class II · Z-1012-2019: The sterile barrier may contain packaging seal defects.
- Dec 26, 2018 · Class II · Z-1013-2019: The sterile barrier may contain packaging seal defects.
- Apr 27, 2010 · Not classified · Z-1979-2010: Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the de
- Apr 27, 2010 · Not classified · Z-1994-2010: Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the de
- Apr 27, 2010 · Not classified · Z-1984-2010: Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the de
- Apr 27, 2010 · Not classified · Z-1977-2010: Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the de
- Apr 27, 2010 · Not classified · Z-1975-2010: Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the de
- Apr 27, 2010 · Not classified · Z-1991-2010: Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the de
- Apr 27, 2010 · Not classified · Z-1983-2010: Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the de
- Apr 27, 2010 · Not classified · Z-1981-2010: Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the de
- Apr 27, 2010 · Not classified · Z-1985-2010: Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the de
- Apr 27, 2010 · Not classified · Z-1993-2010: Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the de
- Apr 27, 2010 · Not classified · Z-1988-2010: Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the de
- Apr 27, 2010 · Not classified · Z-197-2010: Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the de
- Apr 27, 2010 · Not classified · Z-1976-2010: Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the de
- Apr 27, 2010 · Not classified · Z-1980-2010: Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the de
- Apr 27, 2010 · Not classified · Z-1992-2010: Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the de
- Apr 27, 2010 · Not classified · Z-1990-2010: Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the de
- Apr 27, 2010 · Not classified · Z-1982-2010: Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the de
- Apr 27, 2010 · Not classified · Z-1986-2010: Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the de
- Apr 27, 2010 · Not classified · Z-1989-2010: Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the de
- Apr 27, 2010 · Not classified · Z-1987-2010: Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the de
- Apr 2, 2008 · Not classified · Z-2105-2008: Rapid Exchange Biliary Stent may be mislabeled as Flexima biliary Stent, which has a different delivery system included in the package.

## Indications for use
The New Microvasive® Biliary Stent and Delivery System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

Source page: https://510kreport.com/device/K965147
Methodology: https://510kreport.com/methodology