DeviceClearance

K153347

Substantially Equivalent

Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit

Applicant
Codman & Shurtleff, Inc.
Product code
GWM
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Raynham, MA, 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, through . 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.