DeviceClearance

K911897

Substantially Equivalent

GASPARAITIS ESOPHAGRAM CATHETER SET

Applicant
E-Z-Em, Inc.
Product code
KNT
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Worcester, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code KNT

product code KNT
Death
192
Injury
6,034
Malfunction
4,049
Other
1
Total
10,276

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.