Cleared Traditional

IRRIGATION SYSTEM

K840268 · Coloplast A/S · Gastroenterology & Urology
Apr 1984
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K840268 is an FDA 510(k) clearance for the IRRIGATION SYSTEM, a Irrigator, Ostomy (Class II — Special Controls, product code EXD), submitted by Coloplast A/S (Mchenry, US). The FDA issued a Cleared decision on April 5, 1984, 73 days after receiving the submission on January 23, 1984. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5895.

Submission Details

510(k) Number K840268 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 1984
Decision Date April 05, 1984
Days to Decision 73 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code EXD — Irrigator, Ostomy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5895