Cleared Traditional

K230400 - Cure Catheter Closed System

Also marketed or referenced as:
Cure Dextra Closed System

K230400 is an FDA 510(k) clearance for Cure Catheter Closed System, manufactured by Convatec, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K230400 · Convatec, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2023
Decision
266d
Days
Class 2
Risk

K230400 is an FDA 510(k) clearance for the Cure Catheter Closed System. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Convatec, Inc. (Greensboro, US). The FDA issued a Cleared decision on November 8, 2023 after a review of 266 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, Inc. devices

FDA 510(k) Submission Details - K230400

510(k) Number K230400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received February 15, 2023
Decision Date November 08, 2023
Days to Decision 266 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 130d · This submission: 266d
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 49
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K230400.
Luja female (20051)
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Luja Coude (20108 Male CH18 - large packaging)
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Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging)
K230165 · Coloplast · Aug 2023
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