XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set— 510(k) K242003

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K242003 for XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set, Substantially Equivalent on 2024-12-16. Applicant: Aesculap, Inc..

Clearance details

Applicant: Aesculap, Inc.
Product code: Code JXG
Advisory panel: Neurology
Date received: 2024-07-09
Decision date: 2024-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

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.