BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER— 510(k) K041464

Name: FDA 510(k) clearance K041464
Creator: U.S. Food and Drug Administration
Published: 2004-11-05

Substantially Equivalent

Busse Hospital Disposables

FDA 510(k) clearance K041464 for BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER, Substantially Equivalent on 2004-11-05. Applicant: Busse Hospital Disposables. Device class: 2.

Clearance details

Applicant: Busse Hospital Disposables
Product code: Code EZD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2004-06-02
Decision date: 2004-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hauppauge, NY, US

Download summary PDF View on FDA.gov ↗

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K253295 — Coude Sleeved IC; Coude Plus Sleeved IC2026-05-18

More clearances from Busse Hospital Disposables

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K141285 — BUSSE EXTENSION SET2015-02-19
K110883 — J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA2011-06-08
K093920 — BUSSE EPIDURAL CATHETER KIT2010-08-06

Adverse events under product code EZD

product code EZD

Injury: 864
Malfunction: 2,210
Total: 3,074

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.