DeviceClearance

K830483

Substantially Equivalent

COONS SOFT STENT

Applicant
Medi-Tech, Inc.
Product code
FGE
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FGE

product code FGE
Death
52
Injury
2,347
Malfunction
9,798
Other
1
Total
12,198

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.