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
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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.

View all Coloplast A/S devices

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
106d faster than avg
Panel avg: 130d · 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