Rusch Intermittent Urethral Catheters— 510(k) K173596

Name: FDA 510(k) clearance K173596
Creator: U.S. Food and Drug Administration
Published: 2018-01-29

Substantially Equivalent

Teleflex Medical

FDA 510(k) clearance K173596 for Rusch Intermittent Urethral Catheters, Substantially Equivalent on 2018-01-29. Applicant: Teleflex Medical. Device class: 2.

Clearance details

Applicant: Teleflex Medical
Product code: Code EZC
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2017-11-21
Decision date: 2018-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morrisville, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EZC

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K222279 — Rusch Intermittent Urethral Catheters2022-08-29
K946282 — UNIVERSAL URETHRAL CATHETER1995-03-31
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K910846 — BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF1991-08-16
K910195 — BARD HYDROGEL-COATED FOLEY CATHETERS1991-08-09

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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.