Cleared Special

OSTOMY IRRIGATION SET

K121833 · Coloplast A/S · Gastroenterology & Urology
Jul 2012
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K121833 is an FDA 510(k) clearance for the OSTOMY IRRIGATION SET, a Irrigator, Ostomy (Class II — Special Controls, product code EXD), submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on July 16, 2012, 24 days after receiving the submission on June 22, 2012. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5895.

Submission Details

510(k) Number K121833 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2012
Decision Date July 16, 2012
Days to Decision 24 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

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