HAEMATURIA CATHETERS— 510(k) K841511

Substantially Equivalent

Warne Surgical Products, Ltd.

FDA 510(k) clearance K841511 for HAEMATURIA CATHETERS, Substantially Equivalent on 1984-07-12. Applicant: Warne Surgical Products, Ltd..

Clearance details

Applicant: Warne Surgical Products, Ltd.
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 1984-04-11
Decision date: 1984-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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.