510(k) · Decided
DecidedPeripheral Ave Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Peripheral Ave · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Nov 25, 1998 after an 89-day review. The FDA summary names its predicate without a number. 18 later devices descend from it.
- Decided
- Nov 25, 1998
- Review
- 89 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 4 citing it directly.
- This deviceK983008 Peripheral Ave Stent SystemPeripheral Ave · 1998
- Descendant · cites it directly · 8 of its ownK030053 Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680…Jomed AG · 2003
- Descendant · 2 generations on · 7 of its ownK033537 Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005…Abbott Laboratories · 2003
- Descendant · cites it directly · 6 of its ownK993145 Medtronic Ave Bridge StentMedtronic Ave, Inc. · 1999
- Descendant · cites it directly · 6 of its ownK992569 Medtronic Ave Bridge StentMedtronic Ave, Inc. · 1999
- Descendant · 2 generations on · 5 of its ownK011817 Bridge FXMedtronic Ave, Inc. · 2001
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K030053Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810Jomed AG · 2003 · cites it directly8descendants
- K033537Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006…Abbott Laboratories · 2003 · 2 generations on7descendants
- K993145Medtronic Ave Bridge StentMedtronic Ave, Inc. · 1999 · cites it directly6descendants
- K992569Medtronic Ave Bridge StentMedtronic Ave, Inc. · 1999 · cites it directly6descendants
- K011817Bridge FXMedtronic Ave, Inc. · 2001 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983008 | Peripheral Ave Stent System | Peripheral Ave | 1998 | — |
| +1 | K030053 | Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808… | Jomed AG | 2003 | — |
| +2 | K033537 | Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005, EX8L2006… | Abbott Laboratories | 2003 | — |
| +1 | K993145 | Medtronic Ave Bridge Stent | Medtronic Ave, Inc. | 1999 | — |
| +1 | K992569 | Medtronic Ave Bridge Stent | Medtronic Ave, Inc. | 1999 | — |
| +2 | K011817 | Bridge FX | Medtronic Ave, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 3 | 0 |
| 2001 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | — | Johnson & Johnson Interventional Systems’ PALMAZ™ Balloon-Expandable Stent Named without a submission number |
What descends from it? (18)
See all 184 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K030053 (Jomed AG, 2003) has gone furthest, with 8 descendants of its own.
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.
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 Peripheral AVE Biliary Stent System is intended to maintain patency of biliary duct which is occluded by a malignant tumor.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983008 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983008: Peripheral Ave Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983008
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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