DeviceClearance

K842397

Substantially Equivalent

URIHESIVE SYS MALE EXTERNAL CATHETER

Applicant
Convatec, A Division of E.R. Squibb & Sons
Product code
KNX
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code KNX

product code KNX
Malfunction
1,064
Total
1,064

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.