LATEX URINARY CATHETERS— 510(k) K831369

Name: FDA 510(k) clearance K831369
Creator: U.S. Food and Drug Administration
Published: 1983-05-27

Substantially Equivalent

Wayne Surgical Products

FDA 510(k) clearance K831369 for LATEX URINARY CATHETERS, Substantially Equivalent on 1983-05-27. Applicant: Wayne Surgical Products. Device class: 2.

Clearance details

Applicant: Wayne Surgical Products
Product code: Code KOD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1983-04-26
Decision date: 1983-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KOD

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K251864 — Rubber Utility Catheter2026-02-23
K220036 — Wellead Ureteral Catheter2022-12-16
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

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.