# K133700: Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery System and Pushers

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: May 14, 2014 after 162 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K834468 (1984). 5 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900923: Zimmon Endoscopic Pancreatic Stent, Wilson-Cook Medical, Inc. (1990) Summary page 1.
- K101314: Advanix Biliary Stent with Naviflex RX Delivery System, Boston Scientific Corp (2010) Summary page 1.

## Most influential descendants
- K243412: ARCHIMEDES Biodegradable Pancreatic Stent (2025), 1 descendant of its own
- K223592: Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers (2022), 1 descendant of its own
- K260835: ARCHIMEDES Biodegradable Stent (Medium) (2026), 0 descendants of its own
- K251291: Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers (2025), 0 descendants of its own

## Recalls of this device
- Oct 21, 2019 · Class II · Z-0553-2020: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
- Oct 21, 2019 · Class II · Z-0548-2020: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
- Oct 21, 2019 · Class II · Z-0549-2020: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
- Oct 21, 2019 · Class II · Z-0551-2020: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
- Oct 21, 2019 · Class II · Z-0554-2020: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
- Oct 21, 2019 · Class II · Z-0550-2020: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
- Oct 21, 2019 · Class II · Z-0552-2020: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
- Oct 21, 2019 · Class II · Z-0556-2020: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
- Oct 21, 2019 · Class II · Z-0557-2020: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
- Oct 21, 2019 · Class II · Z-0559-2020: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
- Oct 21, 2019 · Class II · Z-0555-2020: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
- Oct 21, 2019 · Class II · Z-0558-2020: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
- Oct 21, 2019 · Class II · Z-0560-2020: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life

## Indications for use
The Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers are intended for delivery of the stent to the pancreatic duct (PD): - Used to drain pancreatic ducts

Source page: https://510kreport.com/device/K133700
Methodology: https://510kreport.com/methodology