510(k) · Cleared
Recalled · Class II · 2019Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery System and Pushers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on May 14, 2014 as substantially equivalent to K900923 (Wilson-Cook Medical, Inc., 1990) and 1 other predicate after a 162-day review. Its family tree reaches back 3 generations to 1984. 4 later devices descend from it. It has been recalled 13 times.
- Decided
- May 14, 2014
- Review
- 162 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 13
- Predicates
- 2
Its longest line of descent runs back 3 generations to K834468 (1984). 5 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK834468 Drainage StentMicrovasive · 1984 · Recalled
- 2 generations backK965147 Biliary Stent, Biliary Stent System, Biliary EndoprosthesisBoston Scientific Corp · 1997 · Recalled
- 1 generation backK101314 Advanix Biliary Stent with Naviflex RX Delivery SystemBoston Scientific Corp · 2010
- This deviceK133700 Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic…Boston Scientific Corporation · 2014
- Descendant · cites it directly · 1 of its ownK243412 ARCHIMEDES Biodegradable Pancreatic StentQ3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) · 2025
- Descendant · cites it directly · 1 of its ownK223592 Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX)…Boston Scientific Corporation · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK260835 ARCHIMEDES Biodegradable Stent (Medium)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) · 2026
- Descendant · 2 generations on · 0 of its ownK251291 Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX)…Boston Scientific · 2025
Most influential descendants
Showing 4 of 4 · See all- K243412ARCHIMEDES Biodegradable Pancreatic StentQ3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) · 2025 · cites it directly1descendant
- K223592Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System…Boston Scientific Corporation · 2022 · cites it directly1descendant
- K260835ARCHIMEDES Biodegradable Stent (Medium)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) · 2026 · 2 generations on0descendants
- K251291Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System…Boston Scientific · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K834468 | Drainage Stent | Microvasive | 1984 | 2 |
| −2 | K965147 | Biliary Stent, Biliary Stent System, Biliary Endoprosthesis | Boston Scientific Corp | 1997 | 23 |
| −1 | K101314 | Advanix Biliary Stent with Naviflex RX Delivery System | Boston Scientific Corp | 2010 | — |
| 0 (this device) | K133700 | Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery… | Boston Scientific Corporation | 2014 | — |
| +1 | K243412 | ARCHIMEDES Biodegradable Pancreatic Stent | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 2025 | — |
| +1 | K223592 | Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic… | Boston Scientific Corporation | 2022 | 1 |
| +2 | K260835 | ARCHIMEDES Biodegradable Stent (Medium) | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 2026 | — |
| +2 | K251291 | Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic… | Boston Scientific | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FGE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FGE device
- #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K900923 | Zimmon Endoscopic Pancreatic StentSummary page 1…Zimmnon Endoscopic Pancreatic Stent Trade Name: Geenen Pancreatic Stent Manufacturer and Clearance Number: Wilson-Cook, K900923 Classification Name: Biliary Catheters and Accessories Product Code: FOE - Bil… | 1990 |
| * | K101314 | Advanix Biliary Stent with Naviflex RX Delivery SystemSummary page 1…xTM Biliary Stent with NaviFlexTm RX Delivery System Manufacturer and Clearance Number: Boston Scientific Corporation, K 1013 14 Classification Name: Biliary Catheters and Accessories Product Code: FOE - lBi… | 2010 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 21, 2019 | Class II | Z-0553-2020 | Incorrect or no expiration date | 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 | Incorrect or no expiration date | 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 | Incorrect or no expiration date | 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 | Incorrect or no expiration date | 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 | Incorrect or no expiration date | 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 | Incorrect or no expiration date | 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 | Incorrect or no expiration date | 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 | Incorrect or no expiration date | 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 | Incorrect or no expiration date | 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 | Incorrect or no expiration date | 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 | Incorrect or no expiration date | 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 | Incorrect or no expiration date | 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 | Incorrect or no expiration date | 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 |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 13.1 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K243412 (Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.), 2025) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K900923.
How does its category compare?
All FGE devicesFGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FGE
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGE
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGE
1,923in 2025
MAUDE reports naming product code FGE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 316 | 54 | 1,006 |
| 2008 | 11 | 214 | 93 | 1,465 |
| 2009 | 7 | 160 | 18 | 1,655 |
| 2010 | 9 | 81 | 32 | 1,434 |
| 2011 | 9 | 114 | 2 | 1,321 |
| 2012 | 8 | 96 | 4 | 1,183 |
| 2013 | 5 | 161 | 3 | 1,060 |
| 2014 | 8 | 156 | 0 | 1,270 |
| 2015 | 8 | 79 | 0 | 1,543 |
| 2016 | 4 | 49 | 0 | 1,453 |
| 2017 | 9 | 59 | 1 | 1,515 |
| 2018 | 7 | 215 | 43 | 1,681 |
| 2019 | 2 | — | 13 | 1,896 |
| 2020 | 4 | 121 | 1 | 2,182 |
| 2021 | 1 | — | 27 | 2,297 |
| 2022 | 6 | 101 | 21 | 1,749 |
| 2023 | 6 | 199 | 19 | 1,615 |
| 2024 | 6 | 188 | 1 | 1,948 |
| 2025 | 7 | 257 | 0 | 1,923 |
| 2026 | 8 | 153 | 11 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133700 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133700: Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery System and Pushers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133700
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026