Codman® Distal Peritoneal Catheter, Barium Open End (82-1682) +1 more— 510(k) K261004
Substantially EquivalentIntegra Lifesciences Production Corporation
FDA 510(k) clearance K261004 for Codman® Distal Peritoneal Catheter, Barium Open End (82-1682) +1 more, Substantially Equivalent on 2026-06-23. Applicant: Integra Lifesciences Production Corporation. Device class: 2.
Summary
Integra Lifesciences Production Corporation's clearance covers two Codman peritoneal catheters: the Distal Peritoneal Catheter, Barium Open End (82-1682) and the HOLTER Peritoneal Catheter (SALMON Design) (82-1684). They're filed under JXG, central nervous system shunts and components.
Class II, 21 CFR 882.5550. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Integra filed from Mansfield, Massachusetts. Review took 89 calendar days (March 26 to June 23, 2026).
Clearance details
- Device name as filed
- Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)
- Applicant
- Integra Lifesciences Production Corporation
- Product code
- Product 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
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view all- K243552 — Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761) +1 more
- 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
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.