CURE CATHETER CLOSED SYSTEM— 510(k) K080881

Name: FDA 510(k) clearance K080881
Creator: U.S. Food and Drug Administration
Published: 2008-06-11

Substantially Equivalent

Cure Medical, LLC

FDA 510(k) clearance K080881 for CURE CATHETER CLOSED SYSTEM, Substantially Equivalent on 2008-06-11. Applicant: Cure Medical, LLC. Device class: 2.

Clearance details

Applicant: Cure Medical, LLC
Product code: Code KOD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2008-03-31
Decision date: 2008-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Niguel, CA, US

Download summary PDF View on FDA.gov ↗

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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.