Cleared Traditional

K881636 - CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE) (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K881636 · Coloplast A/S · Gastroenterology & Urology device
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Jul 1988
Decision
90d
Days
Class 1
Risk

K881636 is an FDA 510(k) clearance for the CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE). Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by Coloplast A/S (Fort Woth, US). The FDA issued a Cleared decision on July 13, 1988 after a review of 90 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

Submission Details

510(k) Number K881636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1988
Decision Date July 13, 1988
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
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.