510(k) · Cleared
Recalled · 2011Multipurpose, Nephrostomy and Biliary Drainage Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Navilyst Medical, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Dec 31, 2009 as substantially equivalent to K023870 (Boston Scientific/Medi-Tech, 2002) and 2 other predicates after a 62-day review. Its family tree reaches back 1 generation to 1994. 5 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 31, 2009
- Review
- 62 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 1 generation to K944290 (1994). 3 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK944290 Catheters, Biliary Catheters, UrologicalBoston Scientific Corp · 1994 · Recalled
- This deviceK093392 Multipurpose, Nephrostomy and Biliary Drainage CathetersNavilyst Medical, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK152069 Exodus Array Multipurpose Drainage Catheter, Exodus Nuance…Navilyst Medical, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK173035 Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail…Cook Incorporated · 2018 · Recalled
- Descendant · cites it directly · 1 of its ownK103353 Multipurpose Drainage Catheter; Nephrostomy Drainage Catheter…Navilyst Medical, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK191498 Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with…Cook Incorporated · 2020
- Descendant · cites it directly · 0 of its ownK111315 Multipurpose Drainage CatheterNavilyst Medical, Inc. · 2011
Most influential descendants
Showing 5 of 5 · See all- K152069Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage…Navilyst Medical, Inc. · 2015 · cites it directly2descendants
- K173035Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter…Cook Incorporated · 2018 · 2 generations on1descendant
- K103353Multipurpose Drainage Catheter; Nephrostomy Drainage Catheter; Biliary Drainage CatheterNavilyst Medical, Inc. · 2011 · cites it directly1descendant
- K191498Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane…Cook Incorporated · 2020 · 3 generations on0descendants
- K111315Multipurpose Drainage CatheterNavilyst Medical, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944290 | Catheters, Biliary Catheters, Urological | Boston Scientific Corp | 1994 | 5 |
| 0 (this device) | K093392 | Multipurpose, Nephrostomy and Biliary Drainage Catheters | Navilyst Medical, Inc. | 2009 | — |
| +1 | K152069 | Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy… | Navilyst Medical, Inc. | 2015 | — |
| +2 | K173035 | Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage… | Cook Incorporated | 2018 | 3 |
| +1 | K103353 | Multipurpose Drainage Catheter; Nephrostomy Drainage Catheter; Biliary… | Navilyst Medical, Inc. | 2011 | — |
| +3 | K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc… | Cook Incorporated | 2020 | — |
| +1 | K111315 | Multipurpose Drainage Catheter | Navilyst Medical, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2015 | 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? (3)
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 |
|---|---|---|---|
| * | K023870 | Flexima Biliary CatheterSummary page 1…Name: FGE-Catheter, Biliary, Diagnostic Regulation Number: 21 CFR§876.5010, Class 11 Premarket K023870 Notification: Boston Scientific Corporation Flexima Drainage… | 2002 |
| * | K944290 | Catheters, Biliary Catheters, UrologicalSummary page 1…FFA-Tube, Drainage, Subrapubic 2ICFR§876.5090, Class 11 K944290 Angiodynamnics Total Abscession Biliary Drainage… | 1994 |
| * | K060023 | Angiodynamics Total Abscession Biliary Drainage CatheterSummary page 1…FGE-Catheter, Biliary, Diagnostic 21CFR§876.5010, Class 11 K060023 5-2… | 2006 |
What descends from it? (5)
3 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 |
|---|---|---|---|---|
| Feb 4, 2011 | Not classified | Z-0647-2012 | Nonconforming Material/Component | Navilyst Medical, Inc. determined that the Exodus Standard Loop Biliary Drainage Catheters exhibited a rate of reported failures (catheter tip fragmentation) higher than anticipated. |
| Feb 4, 2011 | Not classified | Z-0648-2012 | Nonconforming Material/Component | Navilyst Medical, Inc. determined that the Exodus Standard Loop Biliary Drainage Catheters exhibited a rate of reported failures (catheter tip fragmentation) higher than anticipated. |
| May 24, 2010 | Not classified | Z-0015-2011 | Employee error | One box containing five catheters did not complete the sterilization process prior to distribution. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2009, 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?
Multipurpose Drainage: Catheters are intended for percutaneous drainage of fluid in the chest. abdomen and pelvis, e.g., abscesses, cysts, biliary, nephrostonny, uri nary, pleural empyemas, lung abscesses, and mediastinal collections.
Nephrostomy Drainage: Catheters are intended for percutaneous drainage of fluid collections in the urinary system.
Biliary Drainage: Catheters are intended for percutaneous drainage of the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093392: Multipurpose, Nephrostomy and Biliary Drainage Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093392
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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