IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit— 510(k) K192289

Name: FDA 510(k) clearance K192289
Creator: U.S. Food and Drug Administration
Published: 2019-11-15

Substantially Equivalent

Irras USA, Ltd.

FDA 510(k) clearance K192289 for IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit, Substantially Equivalent on 2019-11-15. Applicant: Irras USA, Ltd.. Device class: 2.

Clearance details

Applicant: Irras USA, Ltd.
Product code: Code JXG
Device class: Class 2
Regulation: 21 CFR 882.5550
Advisory panel: Neurology
Date received: 2019-08-23
Decision date: 2019-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JXG

view all

K261004 — Codman® Distal Peritoneal Catheter, Barium Open End (82-1682) +1 more2026-06-23
K251598 — Intellidrop2025-12-10
K250636 — Sophy Mini Monopressure Valve (SM1)2025-11-28
K252514 — EVAC-MRI2025-11-05
K243531 — Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology2025-08-08

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, 2020-01-01 through 2026-04-23. 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.