CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED— 510(k) K132500

Name: FDA 510(k) clearance K132500
Creator: U.S. Food and Drug Administration
Published: 2013-12-23

Substantially Equivalent

Cure Medical, LLC

FDA 510(k) clearance K132500 for CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED, Substantially Equivalent on 2013-12-23. Applicant: Cure Medical, LLC. Device class: 2.

Clearance details

Applicant: Cure Medical, LLC
Product code: Code EZD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2013-08-09
Decision date: 2013-12-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Henderson, NV, US

Download summary PDF View on FDA.gov ↗

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More clearances from Cure Medical, LLC

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K110653 — CURE CATHETER2011-08-01
K080881 — CURE CATHETER CLOSED SYSTEM2008-06-11
K072539 — CURE CATHETER2007-09-13

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.