Cleared Special

K233101 - Luja Coude (20108 Male CH18 - large pac...

K233101 is the FDA 510(k) clearance for Luja Coude (20108 Male CH18 - large pac... by Coloplast Corp.. It is a Class 2 Gastroenterology & Urology device (product code EZD) cleared through the Special 510(k) pathway after a 30-day FDA review.

K233101 · Coloplast Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
30d
Days
Class 2
Risk

K233101 is an FDA 510(k) clearance for the Luja Coude (20108 Male CH18 - large packaging). Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on October 26, 2023 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Coloplast Corp. devices

Submission Details

510(k) Number K233101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2023
Decision Date October 26, 2023
Days to Decision 30 days
Submission Type Special
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
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 47
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K233101.
Sleeved IC 2 Family
K233524 · Hollister Incorporated · May 2024
GentleCath Air for Women (CH10)
K232665 · Convatec · Jan 2024
Cure Catheter Closed System
K230400 · Convatec, Inc. · Nov 2023
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
PVC Hydrophilic Urethral Catheter
K220722 · Well Lead Medical Co., Ltd. · May 2023
SimPro™ Now, GentleCath™ Hydrophilic
K223756 · Dentsply Sirona · May 2023