Cleared Traditional

Luja female (20051) (K241028) - FDA 510(k) Clearance

Also marketed or referenced as:
Luja female (20052) Luja female (20054) Luja female (20056)

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

K241028 · Coloplast · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
102d
Days
Class 2
Risk

K241028 is an FDA 510(k) clearance for the Luja female (20051). Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Coloplast (Plymouth, US). The FDA issued a Cleared decision on July 26, 2024 after a review of 102 days - within the typical 510(k) review window.

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 K241028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2024
Decision Date July 26, 2024
Days to Decision 102 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
28d faster than avg
Panel avg: 130d · This submission: 102d
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 K241028.
Luja Set
K250270 · Coloplast Corp. · Apr 2025
SureCath Set
K242049 · Coloplast Corp. · Nov 2024
Luja Coude
K241210 · Coloplast Corp. · Nov 2024
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