Cleared Traditional

Luja Coud?

K251116 · Coloplast Corp. · Gastroenterology & Urology
Jun 2025
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K251116 is an FDA 510(k) clearance for the Luja Coud?, a Catheter, Straight (Class II — Special Controls, product code EZD), submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on June 27, 2025, 77 days after receiving the submission on April 11, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K251116 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2025
Decision Date June 27, 2025
Days to Decision 77 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code EZD — Catheter, Straight
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130

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