Cleared Special

K121833 - OSTOMY IRRIGATION SET

K121833 is an FDA 510(k) clearance for OSTOMY IRRIGATION SET, manufactured by Coloplast A/S. The device is a Class 2 Gastroenterology & Urology device with product code EXD cleared through the Special 510(k) pathway after a 24-day FDA review.

K121833 · Coloplast A/S · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
24d
Days
Class 2
Risk

K121833 is an FDA 510(k) clearance for the OSTOMY IRRIGATION SET. Classified as Irrigator, Ostomy (product code EXD), Class II - Special Controls.

Submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on July 16, 2012 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5895 - 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 - K121833

510(k) Number K121833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 131d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

EXD Device Classification - Class 2, Special Controls

Product Code EXD Irrigator, Ostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5895
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 - EXD Irrigator, Ostomy

All 7
Devices cleared under the same product code (EXD) and FDA review panel - the closest regulatory comparables to K121833.
URINARY DIVERSION EVACUATING CATHETER
K914692 · Cook Urological, Inc. · Jul 1992
IRRIGATION SYSTEM
K840268 · Coloplast A/S · Apr 1984
VISI-FLOW IRRIGATOR
K832299 · Convatec, A Division of E.R. Squibb & Sons · Aug 1983
UNI-TIP COLOSTOMY IRRIGATION CONE
K823274 · Howmedica Corp. · Dec 1982
SUR-FIT IRRIGATION SLEEVE
K811160 · E. R. Squibb & Sons, Inc. · Jun 1981
TUBE, GASTRO-ENTEROSTOMY
K760810 · Sherwood Medical Industries · Feb 1977
K121833 · OSTOMY IRRIGATION SET
Download PDF FDA Summary Coloplast A/S