Cleared Traditional

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) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230165 · Coloplast · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
217d
Days
Class 2
Risk

K230165 is an FDA 510(k) clearance for the Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (2011.... Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Coloplast (Plymouth, US). The FDA issued a Cleared decision on August 25, 2023 after a review of 217 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 Coloplast devices

Submission Details

510(k) Number K230165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2023
Decision Date August 25, 2023
Days to Decision 217 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
87d slower than avg
Panel avg: 130d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 42
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K230165.
GentleCath Air for Women (CH10)
K232665 · Convatec · Jan 2024
Cure Catheter Closed System
K230400 · Convatec, Inc. · Nov 2023
Luja Coude (20108 Male CH18 - large packaging)
K233101 · Coloplast Corp. · Oct 2023
PVC Hydrophilic Urethral Catheter
K220722 · Well Lead Medical Co., Ltd. · May 2023
SimPro™ Now, GentleCath™ Hydrophilic
K223756 · Dentsply Sirona · May 2023
Intermittent nelaton catheter for single use
K222677 · Hangzhou Jimushi Meditech Co., Ltd. · Apr 2023