510(k) · Cleared
ClearedModification to: GP General Purpose Drainage Catheter, Mini-Pig Drainage Catheter, Nephrostomy Catheter, Biliary
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Uresil, LLC · GBO Catheter, Nephrostomy, General & Plastic Surgery
Cleared on Aug 19, 2004 after a 27-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 19, 2004
- Review
- 27 days
- Class
- Class I
- Product code
- GBO
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GBO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All GBO devicesGBO Catheter, Nephrostomy, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GBO
FDA has decided no GBO device since 2007.
Median 510(k) review, days · GBO
Too few GBO 510(k)s in any year since 2007 to give a median.
Recalls per year · GBO
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GBO
68in 2025
MAUDE reports naming product code GBO, 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 | 0 | — | 0 | 14 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 0 | — | 1 | 5 |
| 2010 | 0 | — | 0 | 8 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 20 |
| 2015 | 0 | — | 0 | 47 |
| 2016 | 0 | — | 0 | 38 |
| 2017 | 0 | — | 0 | 422 |
| 2018 | 0 | — | 0 | 435 |
| 2019 | 0 | — | 1 | 175 |
| 2020 | 0 | — | 0 | 127 |
| 2021 | 0 | — | 0 | 115 |
| 2022 | 0 | — | 0 | 121 |
| 2023 | 0 | — | 0 | 145 |
| 2024 | 0 | — | 0 | 32 |
| 2025 | 0 | — | 0 | 68 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Drainage Catheters are to be used for percutaneous drainage of abscesses, nephrostomies, and other fluids.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K041995 · printed Nov 3, 2026
Cite this page
510(k) Report. “K041995: Modification to: GP General Purpose Drainage Catheter, Mini-Pig Drainage Catheter, Nephrostomy Catheter, Biliary.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K041995
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026