DeviceClearance

K990034

Substantially Equivalent

WILSON-COOK COLONIC Z-STENT

Applicant
Med Institute, Inc.
Product code
MQR
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
West Lafayette, IN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MQR

product code MQR
Death
11
Injury
149
Total
160

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.