Cleared Traditional

K221929 - Smith+Nephew INTELLIO Tablet (FDA 510(k) Clearance)

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

K221929 · Smith & Nephew · General & Plastic Surgery device
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Sep 2022
Decision
67d
Days
Class 2
Risk

K221929 is an FDA 510(k) clearance for the Smith+Nephew INTELLIO Tablet. 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 September 6, 2022 after a review of 67 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Smith & Nephew devices

Submission Details

510(k) Number K221929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2022
Decision Date September 06, 2022
Days to Decision 67 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 114d · This submission: 67d
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.