Cleared Special

K263512 - Luja female

K263512 is an FDA 510(k) clearance for Luja female, manufactured by Coloplast Corp.. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Special 510(k) pathway after a 29-day FDA review.

K263512 · Coloplast Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
29d
Days
Class 2
Risk

K263512 is an FDA 510(k) clearance for the Luja female. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Coloplast Corp. (Minneapolis, US). The FDA issued a Cleared decision on October 28, 2026 after a review of 29 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.

FDA 510(k) Submission Details - K263512

510(k) Number K263512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2026
Decision Date October 28, 2026
Days to Decision 29 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
102d faster than avg
Panel avg: 131d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 87
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K263512.
Liquick X-treme, Liquick X-treme Plus
K261418 · Teleflex Medical · Sep 2026
Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16)
K260737 · Convatec · Aug 2026
LoFric Origo Pro Coudé
K261658 · Wellspect AB · Jul 2026
Luja Soft
K262045 · Coloplast A/S · Jul 2026
Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)
K260394 · Hangzhou Jimushi Meditech Co., Ltd. · Jun 2026
Coude Sleeved IC
K253295 · Hollister Incorporated · May 2026
K263512 · Luja female
Download PDF FDA Summary Coloplast Corp.