Cleared Traditional

K083785 - VITALA CONTINENCE CONTROL DEVICE (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K083785 · Convatec · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
469d
Days
Class 1
Risk

K083785 is an FDA 510(k) clearance for the VITALA CONTINENCE CONTROL DEVICE. Classified as Pouch, Colostomy (product code EZQ), Class I - General Controls.

Submitted by Convatec (Skillman, US). The FDA issued a Cleared decision on April 2, 2010 after a review of 469 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Convatec devices

Submission Details

510(k) Number K083785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2008
Decision Date April 02, 2010
Days to Decision 469 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
339d slower than avg
Panel avg: 130d · This submission: 469d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EZQ Pouch, Colostomy
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.