510(k) · Decided
DecidedSuresave TM Self-Expandable Nitinol Stent and Precision TM Delivery Catheter-SS06120060
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Idev Technologies, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Aug 15, 2006 as substantially equivalent to K051379 (Ev3 Corporation, 2005) and 1 other predicate after a 166-day review. Its family tree reaches back 5 generations to 2001. 6 later devices descend from it.
- Decided
- Aug 15, 2006
- Review
- 166 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K010445 (2001). 11 ancestors in all, the oldest K971010 (1997). 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK010445 Precise Nitinol Stent Transhepatic Billary SystemCordis Corp. · 2001
- 4 generations backK012993 Modification to Precise Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2001 · Recalled
- 3 generations backK021898 Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2002 · Recalled
- 2 generations backK031777 Modeification to: Smart Control Nitinol Stent Transhepatic Biliary…Cordis Corp. · 2003 · Recalled
- 1 generation backK032457 Modification to Smart Control Nitinol Stent Transhepatic Biliary…Cordis Corp. · 2003
- This deviceK060557 Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery…Idev Technologies, Inc. · 2006
- Descendant · cites it directly · 5 of its ownK071646 Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery…Idev Technologies, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK093893 Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic…Idev Technologies, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 2 of its ownK111766 Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic…Idev Technologies, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK122546 Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic…Idev Technologies, Inc. · 2012
- Descendant · 3 generations on · 0 of its ownK130591 Supera VeritasIdev Technologies, Inc. · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K071646Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery Catheter, Model #…Idev Technologies, Inc. · 2008 · cites it directly5descendants
- K093893Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc. · 2010 · cites it directly4descendants
- K111766Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary SystemsIdev Technologies, Inc. · 2011 · 2 generations on2descendants
- K122546Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc. · 2012 · 2 generations on1descendant
- K130591Supera VeritasIdev Technologies, Inc. · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010445 | Precise Nitinol Stent Transhepatic Billary System | Cordis Corp. | 2001 | — |
| −4 | K012993 | Modification to Precise Nitinol Stent Transhepatic Biliary System | Cordis Corp. | 2001 | 1 |
| −3 | K021898 | Smart Control Nitinol Stent Transhepatic Biliary System | Cordis Corp. | 2002 | 1 |
| −2 | K031777 | Modeification to: Smart Control Nitinol Stent Transhepatic Biliary System | Cordis Corp. | 2003 | 3 |
| −1 | K032457 | Modification to Smart Control Nitinol Stent Transhepatic Biliary System | Cordis Corp. | 2003 | — |
| 0 (this device) | K060557 | Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery… | Idev Technologies, Inc. | 2006 | — |
| +1 | K071646 | Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery Catheter… | Idev Technologies, Inc. | 2008 | — |
| +1 | K093893 | Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary… | Idev Technologies, Inc. | 2010 | 1 |
| +2 | K111766 | Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary… | Idev Technologies, Inc. | 2011 | 1 |
| +2 | K122546 | Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary… | Idev Technologies, Inc. | 2012 | — |
| +3 | K130591 | Supera Veritas | Idev Technologies, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K051379 | Protege RX GPS Self-Expanding Nitrinol Stent | 2005 |
| * | K032457 | Modification to Smart Control Nitinol Stent Transhepatic Biliary SystemSummary page 1…dicate Device: Protege® GPSTM Self-Expanding Nitinol Stent - Biliary (KO51379) SMART TM ControlTM Nitinol Stent Transhepatic - Biliary (K032457) Device Description: The SureSaveTM Self-Expandable Biliary Nitinol Stent and PrecisionTM Stent Delivery Catheter is comprised… | 2003 |
What descends from it? (6)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K071646 (Idev Technologies, Inc., 2008) has gone furthest, with 5 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 SureSave Self-Expandable Biliary Nitinol Stent and Precision Stent Delivery Catheter is intended for use in the palliation of malignant neoplasms in the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060557 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060557: Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery Catheter-SS06120060.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060557
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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