PHTIP DISPOSABLE ISFET CATHETER— 510(k) K102801

Substantially Equivalent

E-Cath Co., Ltd.

FDA 510(k) clearance K102801 for PHTIP DISPOSABLE ISFET CATHETER, Substantially Equivalent on 2010-10-26. Applicant: E-Cath Co., Ltd..

Clearance details

Applicant: E-Cath Co., Ltd.
Product code: Code FFX
Advisory panel: Gastroenterology, Urology
Date received: 2010-09-27
Decision date: 2010-10-26
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, 2020-01-01 through 2026-04-23. 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.