K173596

Substantially Equivalent

Rusch Intermittent Urethral Catheters

Applicant: Teleflex Medical
Product code: EZC
Advisory panel: Gastroenterology, Urology
Date received: 2017-11-21
Decision date: 2018-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morrisville, NC, US

Adverse events under product code EZC

product code EZC

Injury: 772
Malfunction: 6,262
Other: 1
Total: 7,035

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.