510(k) · Cleared
ClearedAngiodynamics Total Abscession Biliary Drainage Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AngioDynamics, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Mar 9, 2006 after a 64-day review. The FDA summary names no predicate by number. 7 later devices descend from it.
- Decided
- Mar 9, 2006
- Review
- 64 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK060023 Angiodynamics Total Abscession Biliary Drainage CatheterAngioDynamics, Inc. · 2006
- Descendant · cites it directly · 5 of its ownK093392 Multipurpose, Nephrostomy and Biliary Drainage CathetersNavilyst Medical, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 2 of its ownK152069 Exodus Array Multipurpose Drainage Catheter, Exodus Nuance…Navilyst Medical, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK173035 Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail…Cook Incorporated · 2018 · Recalled
- Descendant · 2 generations on · 1 of its ownK103353 Multipurpose Drainage Catheter; Nephrostomy Drainage Catheter…Navilyst Medical, Inc. · 2011
- Descendant · 4 generations on · 0 of its ownK191498 Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with…Cook Incorporated · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K093392Multipurpose, Nephrostomy and Biliary Drainage CathetersNavilyst Medical, Inc. · 2009 · cites it directly5descendants
- K152069Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage…Navilyst Medical, Inc. · 2015 · 2 generations on2descendants
- K173035Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter…Cook Incorporated · 2018 · 3 generations on1descendant
- K103353Multipurpose Drainage Catheter; Nephrostomy Drainage Catheter; Biliary Drainage CatheterNavilyst Medical, Inc. · 2011 · 2 generations on1descendant
- K191498Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane…Cook Incorporated · 2020 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060023 | Angiodynamics Total Abscession Biliary Drainage Catheter | AngioDynamics, Inc. | 2006 | — |
| +1 | K093392 | Multipurpose, Nephrostomy and Biliary Drainage Catheters | Navilyst Medical, Inc. | 2009 | 3 |
| +2 | K152069 | Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy… | Navilyst Medical, Inc. | 2015 | — |
| +3 | K173035 | Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage… | Cook Incorporated | 2018 | 3 |
| +2 | K103353 | Multipurpose Drainage Catheter; Nephrostomy Drainage Catheter; Biliary… | Navilyst Medical, Inc. | 2011 | — |
| +4 | K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc… | Cook Incorporated | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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?
The FDA summary names no predicate by number.
What descends from it? (7)
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?
- Of its descendants, K093392 (Navilyst Medical, Inc., 2009) 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 ANGIODYNAMICS Total Abscession Biliary Drainage Catheter is indicated for percutaneous transhepatic biliary drainage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060023 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060023: Angiodynamics Total Abscession Biliary Drainage Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060023
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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