Cleared Traditional

K833569 - COMFEEL BARRIER CREAM

K833569 is the FDA 510(k) clearance for COMFEEL BARRIER CREAM by Coloplast A/S. It is a Class 1 Gastroenterology & Urology device (product code EXB) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K833569 · Coloplast A/S · Gastroenterology & Urology device
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Dec 1983
Decision
76d
Days
Class 1
Risk

K833569 is an FDA 510(k) clearance for the COMFEEL BARRIER CREAM. 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 December 27, 1983 after a review of 76 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Coloplast A/S devices

Submission Details

510(k) Number K833569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1983
Decision Date December 27, 1983
Days to Decision 76 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 130d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 45
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K833569.
BANGORT LIFESTYLE COLOSTOMY POUCHES
K841029 · Howmedica Corp. · 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
ACTIVE LIFE
K833625 · Convatec, A Division of E.R. Squibb & Sons · Nov 1983
SUR-FIT FLEXIBLE
K830945 · Convatec, A Division of E.R. Squibb & Sons · Apr 1983
BARD PROTECTIVE BARRIER FILM
K821271 · C.R. Bard, Inc. · Jul 1982