Cleared Traditional

K181643 - SmartBag (SmartPouch) (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K181643 · 11 Health Technologies Limited · Gastroenterology & Urology device
Nov 2018
Decision
147d
Days
Class 1
Risk

K181643 is an FDA 510(k) clearance for the SmartBag (SmartPouch). Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by 11 Health Technologies Limited (Borehamwood, GB). The FDA issued a Cleared decision on November 16, 2018 after a review of 147 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.

Submission Details

510(k) Number K181643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2018
Decision Date November 16, 2018
Days to Decision 147 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 156d · This submission: 147d
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.