Cleared Traditional

K840265 - MC 2002 OSTOMY POUCHES & SKIN FLANGES (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K840265 · Coloplast A/S · Gastroenterology & Urology device
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Apr 1984
Decision
70d
Days
Class 1
Risk

K840265 is an FDA 510(k) clearance for the MC 2002 OSTOMY POUCHES & SKIN FLANGES. 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 April 2, 1984 after a review of 70 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 K840265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1984
Decision Date April 02, 1984
Days to Decision 70 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
60d faster than avg
Panel avg: 130d · This submission: 70d
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.