INTERMITTENT URETHRAL CATHETERS— 510(k) K033023

Name: FDA 510(k) clearance K033023
Creator: U.S. Food and Drug Administration
Published: 2003-12-23

Substantially Equivalent

Rusch Intl.

FDA 510(k) clearance K033023 for INTERMITTENT URETHRAL CATHETERS, Substantially Equivalent on 2003-12-23. Applicant: Rusch Intl.. Device class: 2.

Clearance details

Applicant: Rusch Intl.
Product code: Code KOD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2003-09-26
Decision date: 2003-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jaffrey, NH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KOD

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K220730 — allFlex Ureteral Catheters, Krait Ureteral Catheters2022-10-13
K211032 — Urinary Catheter 12 Fr, Urinary Catheter 16 Fr2021-11-19
K181979 — Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter2019-05-24

More clearances from Rusch Intl.

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K030559 — RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM2003-06-30
K023666 — RUSCH GUIDED CHOLANGIOGRAPHY CATHETER2003-06-17
K023918 — RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS2003-03-28
K023964 — RUSCH MICROLARYNGEAL TUBE2002-12-23
K021540 — RUSCH EDGAR TUBE2002-08-01

Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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.