Cleared Traditional

K260737 - Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16)

Also marketed or referenced as:
Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18) Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).

K260737 is an FDA 510(k) clearance for Cure Aqua Ready to Use Hydrophilic Inte..., manufactured by Convatec. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K260737 · Convatec · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
152d
Days
Class 2
Risk

K260737 is an FDA 510(k) clearance for the Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16). Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Convatec (Flintshire, GB). The FDA issued a Cleared decision on August 5, 2026 after a review of 152 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Convatec devices

FDA 510(k) Submission Details - K260737

510(k) Number K260737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2026
Decision Date August 05, 2026
Days to Decision 152 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 131d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - EZD Catheter, Straight

All 68
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