DeviceClearance

CURE CATHETER— 510(k) K110653

Substantially Equivalent

Cure Medical, LLC

FDA 510(k) clearance K110653 for CURE CATHETER, Substantially Equivalent on 2011-08-01. 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
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code EZD

product code EZD
Injury
864
Malfunction
2,210
Total
3,074

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K110653

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110653.

Data sourced from openFDA. This site is unofficial and independent of the FDA.