TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP— 510(k) K020780

Substantially Equivalent

Medex, Inc.

FDA 510(k) clearance K020780 for TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP, Substantially Equivalent on 2002-05-20. Applicant: Medex, Inc..

Clearance details

Applicant: Medex, Inc.
Product code: Code GWM
Advisory panel: Neurology
Date received: 2002-03-11
Decision date: 2002-05-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Dublin, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GWM

product code GWM

Death: 21
Injury: 732
Malfunction: 2,063
Other: 1
Total: 2,817

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.