CSF400 AND CSF600— 510(k) K030081

Substantially Equivalent

Inmed Ltda.

FDA 510(k) clearance K030081 for CSF400 AND CSF600, Substantially Equivalent on 2003-10-06. Applicant: Inmed Ltda..

Clearance details

Applicant: Inmed Ltda.
Product code: Code JXG
Advisory panel: Neurology
Date received: 2003-01-09
Decision date: 2003-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, 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.