Rusch Intermittent Urethral Catheters— 510(k) K222279

Substantially Equivalent

Teleflex Medical

FDA 510(k) clearance K222279 for Rusch Intermittent Urethral Catheters, Substantially Equivalent on 2022-08-29. Applicant: Teleflex Medical.

Clearance details

Applicant: Teleflex Medical
Product code: Code EZC
Advisory panel: Gastroenterology, Urology
Date received: 2022-07-29
Decision date: 2022-08-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Morrisville, NC, US

Download summary PDF View on FDA.gov ↗

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.