Cleared Special

Luja Set

K250270 · Coloplast Corp. · Gastroenterology & Urology
Apr 2025
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K250270 is an FDA 510(k) clearance for the Luja Set, a Catheter, Straight (Class II — Special Controls, product code EZD), submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on April 17, 2025, 77 days after receiving the submission on January 30, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K250270 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2025
Decision Date April 17, 2025
Days to Decision 77 days
Submission Type Special
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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