Cleared Traditional

K833565 - COMFEEL PASTE

K833565 is an FDA 510(k) clearance for COMFEEL PASTE, manufactured by Coloplast A/S. The device is a Class 1 Gastroenterology & Urology device with product code EXB cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K833565 · Coloplast A/S · Gastroenterology & Urology device
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Jan 1984
Decision
110d
Days
Class 1
Risk

K833565 is an FDA 510(k) clearance for the COMFEEL PASTE. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by Coloplast A/S (Mchenry, US). The FDA issued a Cleared decision on January 30, 1984 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5900 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Coloplast A/S devices

FDA 510(k) Submission Details - K833565

510(k) Number K833565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1983
Decision Date January 30, 1984
Days to Decision 110 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 130d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

EXB Device Classification - Class 1, General Controls

Product Code EXB Collector, Ostomy
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EXB Collector, Ostomy

All 69
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K833565.
MC 2000 OSTOMY POUCHES
K840269 · Coloplast A/S · Apr 1984
BARD KARAYA GUM WASHERS
K834575 · C.R. Bard, Inc. · Feb 1984
SUR-FIT UROSTOMY POUCH W/ACCUSEAL
K840166 · Convatec, A Division of E.R. Squibb & Sons · Feb 1984
STERILE DRAINAGE SYSTEM
K833571 · Coloplast A/S · Jan 1984
COMFEEL CLEANSER
K833566 · Coloplast A/S · Dec 1983
COMFEEL BARRIER CREAM
K833569 · Coloplast A/S · Dec 1983