Cleared Traditional

K072539 - CURE CATHETER

K072539 is an FDA 510(k) clearance for CURE CATHETER, manufactured by Cure Medical, LLC. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Traditional 510(k) pathway after a 3-day FDA review.

K072539 · Cure Medical, LLC · Gastroenterology & Urology device
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Sep 2007
Decision
3d
Days
Class 2
Risk

K072539 is an FDA 510(k) clearance for the CURE CATHETER. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Cure Medical, LLC (Laguna Niguel, US). The FDA issued a Cleared decision on September 13, 2007 after a review of 3 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cure Medical, LLC devices

FDA 510(k) Submission Details - K072539

510(k) Number K072539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2007
Decision Date September 13, 2007
Days to Decision 3 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
128d faster than avg
Panel avg: 131d · This submission: 3d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

EZD Device Classification - Class 2, Special Controls

Product Code EZD Catheter, Straight
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Underwriters Laboratories, Inc.
CASEY CONRY

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EZD Catheter, Straight

All 75
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K072539.
FOOTPRINT URINARY DRAINAGE CATHETER
K090576 · Footprint Medical · Aug 2009
GRADUATED ADAPTER WITH CLAVE
K080007 · Icu Medical, Inc. · May 2008
NEOMED URINARY CATHETER
K072997 · Neomed, Inc. · Dec 2007
EXPRESSWAY INTERMITTENT CATHETER
K061766 · Percutaneous Systems, Incorporated · Mar 2007
HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT
K062444 · Oasis Medikal Urunler Kimya Sanayi VE Tic A.S. · Feb 2007
MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER
K052440 · Mentor Corporation · Oct 2005

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.