510(k) · Cleared
Recalled · Class II · 2026Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on May 1, 2018 as substantially equivalent to K152069 (Navilyst Medical, Inc., 2015) after a 215-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it. It has been recalled 3 times.
- Decided
- May 1, 2018
- Review
- 215 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 3 generations to K944290 (1994). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK944290 Catheters, Biliary Catheters, UrologicalBoston Scientific Corp · 1994 · Recalled
- 2 generations backK093392 Multipurpose, Nephrostomy and Biliary Drainage CathetersNavilyst Medical, Inc. · 2009 · Recalled
- 1 generation backK152069 Exodus Array Multipurpose Drainage Catheter, Exodus Nuance…Navilyst Medical, Inc. · 2015
- This deviceK173035 Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail…Cook Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK191498 Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with…Cook Incorporated · 2020
Most influential descendants
Showing 1 of 1 · See all- K191498Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane…Cook Incorporated · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944290 | Catheters, Biliary Catheters, Urological | Boston Scientific Corp | 1994 | 5 |
| −2 | K093392 | Multipurpose, Nephrostomy and Biliary Drainage Catheters | Navilyst Medical, Inc. | 2009 | 3 |
| −1 | K152069 | Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy… | Navilyst Medical, Inc. | 2015 | — |
| 0 (this device) | K173035 | Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage… | Cook Incorporated | 2018 | — |
| +1 | K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc… | Cook Incorporated | 2020 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K152069 | Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage…Summary page 6…s: Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, and Exodus Believe Biliary Drainage Catheter cleared on September 24, 2015 (K152069). Device Description: The Gordon Large-Bore Curved Drainage Catheter is a drainage catheter that aspirates abscess cavity cont… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane… | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2026 | Class II | Z-1786-2026 | Incorrect or no expiration date | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| May 15, 2024 | Class II | Z-2223-2024 | Labeling Change Control | Product labels state the incorrect expiration dates that extends beyond their true expiration date |
| May 15, 2024 | Class II | Z-2222-2024 | Labeling Change Control | Product labels state the incorrect expiration dates that extends beyond their true expiration date |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K191498 (Cook Incorporated, 2020) has gone furthest, with 0 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. 2018, 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 Gordon Large-Bore Curved Drainage Catheter is intended for abscess drainage.
The Nephrostomy Pigtail Drainage Catheter and Percutaneous Nephrostomy Set are intended for external urine drainage from the renal pelvis.
The Pigtail Drainage Catheter Needle Set is intended for percutaneous external drainage in multiple applications (e.g., nephrostomy, abscess drainage and other abdominal cavity drainage procedures).
The Multipurpose Drainage Catheters and Sets are intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173035 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173035: Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173035
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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