Cleared Traditional

Flexi-Seal PROTECT Fecal Management System (K162906) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K162906 · Convatec · Gastroenterology & Urology device
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Mar 2017
Decision
141d
Days
Class 2
Risk

K162906 is an FDA 510(k) clearance for the Flexi-Seal PROTECT Fecal Management System. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Convatec (Deeside, GB). The FDA issued a Cleared decision on March 7, 2017 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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 Convatec devices

Submission Details

510(k) Number K162906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2016
Decision Date March 07, 2017
Days to Decision 141 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
11d slower than avg
Panel avg: 130d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNT Tubes, Gastrointestinal (and Accessories)

All 142
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K162906.
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K173355 · Cook Incorporated · Nov 2017
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Barone Jejunostomy Catheter Set
K160567 · Cook Incorporated · May 2017
GastriSail Gastric Positioning System
K143088 · Covidien · Feb 2015
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
K133251 · C.R. Bard, Inc. · May 2014
KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY
K123555 · Covidien · Apr 2014