DeviceClearance

K102801

Substantially Equivalent

PHTIP DISPOSABLE ISFET CATHETER

Applicant
E-Cath Co., Ltd.
Product code
FFX
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Golden, CO, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FFX

product code FFX
Other
1
Total
1

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.