510(k) · Cleared
Recalled · Class II · 2020Codman Bactiseal Endoscopic Venticular Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · JXG Shunt, Central Nervous System And Components
Cleared on May 9, 2011 as substantially equivalent to K934196 (Codman & Shurtleff, Inc., 1994) and 1 other predicate after a 52-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it. It has been recalled once.
- Decided
- May 9, 2011
- Review
- 52 days
- Class
- Class II
- Product code
- JXG
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K934196 (1994). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK934196 Codman Quick Shunt Kit, Cat. #82-6570Codman & Shurtleff, Inc. · 1994
- This deviceK110751 Codman Bactiseal Endoscopic Venticular CatheterCodman & Shurtleff, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK233445 Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal…Integra Lifesciences Production Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK243531 Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production Corporation · 2025
Most influential descendants
Showing 2 of 2 · See all- K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic…Integra Lifesciences Production Corporation · 2024 · cites it directly1descendant
- K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production Corporation · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934196 | Codman Quick Shunt Kit, Cat. #82-6570 | Codman & Shurtleff, Inc. | 1994 | — |
| 0 (this device) | K110751 | Codman Bactiseal Endoscopic Venticular Catheter | Codman & Shurtleff, Inc. | 2011 | — |
| +1 | K233445 | Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic… | Integra Lifesciences Production Corporation | 2024 | — |
| +2 | K243531 | Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology | Integra Lifesciences Production Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 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? (2)
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 |
|---|---|---|---|
| * | K934196 | Codman Quick Shunt Kit, Cat. #82-6570Summary page 1…1 CFR § 882.5550 Product Code: JXG C. Predicate Device: Codman® Neuroguide Endoscopic Placement Catheter (K934 196) Codman® Bactiseal @ Catheters (K003322) D. Device Description: The BACTISEAL Endoscop… | 1994 |
| * | K003322 | Codman Bactiseal CathetersSummary page 1…: Codman® Neuroguide Endoscopic Placement Catheter (K934 196) Codman® Bactiseal @ Catheters (K003322) D. Device Description: The BACTISEAL Endoscopic Ventricular Catheter is designed to be placed with an endoscope, which… | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233445 | Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic… | 2024 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 14, 2020 | Class II | Z-0725-2021 | Labeling Change Control | Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K233445 (Integra Lifesciences Production Corporation, 2024) has gone furthest, with 1 descendant of its own.
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. 2011, this device’s year, is highlighted.
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?
CODMAN® BACTISEAL® Endoscopic Ventricular Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110751 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110751: Codman Bactiseal Endoscopic Venticular Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110751
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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