LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC— 510(k) K121248

Name: FDA 510(k) clearance K121248
Creator: U.S. Food and Drug Administration
Published: 2013-12-13

Substantially Equivalent

Moller Medical GmbH

FDA 510(k) clearance K121248 for LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC, Substantially Equivalent on 2013-12-13. Applicant: Moller Medical GmbH. Device class: 2.

Clearance details

Applicant: Moller Medical GmbH
Product code: Code JXG
Device class: Class 2
Regulation: 21 CFR 882.5550
Advisory panel: Neurology
Date received: 2012-04-25
Decision date: 2013-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Corona, CA, US

Download summary PDF View on FDA.gov ↗

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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.