Cleared Special

K262045 - Luja Soft

K262045 is the FDA 510(k) clearance for Luja Soft by Coloplast A/S. It is a Class 2 Gastroenterology & Urology device (product code EZD) cleared through the Special 510(k) pathway after a 20-day FDA review.

K262045 · Coloplast A/S · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
20d
Days
Class 2
Risk

K262045 is an FDA 510(k) clearance for the Luja Soft. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Coloplast A/S (Minneapolis, US). The FDA issued a Cleared decision on July 7, 2026 after a review of 20 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 A/S devices

Submission Details

510(k) Number K262045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2026
Decision Date July 07, 2026
Days to Decision 20 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
110d faster than avg
Panel avg: 130d · This submission: 20d
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 K262045.
Coude Sleeved IC
K253295 · Hollister Incorporated · May 2026
LoFric Elle Pro
K260999 · Wellspect AB · Apr 2026
GentleCath Air for Men
K252943 · Convatec Limited · Apr 2026
Liv Pre-lubricated Intermittent Catheter
K260502 · HR Healthcare · Mar 2026
EZ-Protect Hydrophilic Closed System Intermittent Catheter
K251274 · HR Healthcare · Jan 2026
Ready to use Nelaton Catheter
K251178 · Jamjoom Fullcare Corporation · Jan 2026