Cleared Traditional

K192876 - INTELLIO Tablet Application (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192876 · Smith & Nephew · General & Plastic Surgery device
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Feb 2020
Decision
142d
Days
Class 2
Risk

K192876 is an FDA 510(k) clearance for the INTELLIO Tablet Application. Classified as Endoscopic Central Control Unit (product code ODA), Class II - Special Controls.

Submitted by Smith & Nephew (Andover, US). The FDA issued a Cleared decision on February 27, 2020 after a review of 142 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K192876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2019
Decision Date February 27, 2020
Days to Decision 142 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 114d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODA Endoscopic Central Control Unit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Control Endoscopic And Other Ancillary Surgical Equipment In One Central Location, Either By Remote Control, Touch Screen, Or Voice Command.
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 General & Plastic Surgery devices follow this clearance model.