Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology— 510(k) K243531
Substantially EquivalentIntegra Lifesciences Production Corporation
FDA 510(k) clearance K243531 for Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology, Substantially Equivalent on 2025-08-08. Applicant: Integra Lifesciences Production Corporation. Device class: 2.
Clearance details
- Applicant
- Integra Lifesciences Production Corporation
- Product code
- Code JXG
- Device class
- Class 2
- Regulation
- 21 CFR 882.5550
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
Recent devices under product code JXG
view allMore clearances from Integra Lifesciences Production Corporation
view all- K232890 — CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
- K233445 — Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter
- K233448 — Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set
- K223330 — Certas Plus Programmable Valves
- K221840 — Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves
Adverse events under product code JXG
product code JXG- Death
- 76
- Injury
- 5,632
- Malfunction
- 2,230
- Other
- 4
- Total
- 7,942
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.