510(k) · Cleared
ClearedModification to Lumbo-Peritoneal Shunts and Lumbar Drainage Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vygon Us, LLC · JXG Shunt, Central Nervous System And Components
Cleared on May 27, 2004 after a 184-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 27, 2004
- Review
- 184 days
- Class
- Class II
- Product code
- JXG
- 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 JXG? 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 JXG device
- #1 K243531 Codman Libertís Shunt Catheter with Bactiseal…score 11.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 JXG devicesJXG Shunt, Central Nervous System And Components: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JXG
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JXG
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JXG
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXG
1,198in 2025
MAUDE reports naming product code JXG, 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 | 3 | 184 | 0 | 649 |
| 2008 | 6 | 60 | 1 | 630 |
| 2009 | 5 | 106 | 30 | 629 |
| 2010 | 3 | 30 | 0 | 812 |
| 2011 | 7 | 136 | 5 | 787 |
| 2012 | 3 | 78 | 1 | 977 |
| 2013 | 3 | 108 | 14 | 1,004 |
| 2014 | 0 | — | 6 | 1,251 |
| 2015 | 6 | 276 | 0 | 984 |
| 2016 | 6 | 143 | 0 | 1,091 |
| 2017 | 7 | 90 | 1 | 1,335 |
| 2018 | 6 | 102 | 0 | 1,484 |
| 2019 | 4 | 101 | 0 | 1,295 |
| 2020 | 2 | — | 8 | 1,206 |
| 2021 | 1 | — | 0 | 1,467 |
| 2022 | 4 | 101 | 0 | 1,329 |
| 2023 | 5 | 134 | 2 | 1,221 |
| 2024 | 3 | 90 | 3 | 1,214 |
| 2025 | 8 | 255 | 0 | 1,198 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
Percutaneous lumbo-peritoneal shunting may be utilized in the treatment of communicating hydrocephalus. It is designed to shunt CSF from the subarachnoid space to the peritoneal cavity. * The shunting may be used for evaluation or treatment of normal pressure communicating hydrocephalus. * A percutaneous lumbo-peritnoeal shunt is also useful in the management of persistent cerebrospinal fluid fistulas, bulging cranial and suboccipital decompressions and…
Read the full statement (110 words)
Percutaneous lumbo-peritoneal shunting may be utilized in the treatment of communicating hydrocephalus. It is designed to shunt CSF from the subarachnoid space to the peritoneal cavity.
* The shunting may be used for evaluation or treatment of normal pressure communicating hydrocephalus.
* A percutaneous lumbo-peritnoeal shunt is also useful in the management of persistent cerebrospinal fluid fistulas, bulging cranial and suboccipital decompressions and transient CSF absorption defects, e.g. post meningitic or post-hemorrhagic hydrocephalus.
Lumbar Drainage System is intended for use as a means of temporary external diversion, pressure monitoring and collection of cerebrospinal fluid from the lumbar space. It was designed for use with the Phoenix Fifth Ventricle Collection Bag.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K033704 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033704: Modification to Lumbo-Peritoneal Shunts and Lumbar Drainage Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033704
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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