Not Cleared Direct

DEN220047 - Galen ES Cooperative Surgical Assistant Platform, Galen ES (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN220047 · Galen Robotics · Ear, Nose, Throat device
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Jul 2023
Decision
362d
Days
Class 2
Risk

DEN220047 is an FDA 510(k) submission (not cleared) for the Galen ES Cooperative Surgical Assistant Platform, Galen ES. Classified as Cooperative Powered Surgical Assist Device For Ent Surgery (product code QXG), Class II - Special Controls.

Submitted by Galen Robotics (Baltimore, US). The FDA issued a Not Cleared (DENG) decision on July 19, 2023 after a review of 362 days.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4460 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 362 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN220047 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 22, 2022
Decision Date July 19, 2023
Days to Decision 362 days
Submission Type Direct
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
273d slower than avg
Panel avg: 89d · This submission: 362d
Pathway characteristics

Device Classification

Product Code QXG Cooperative Powered Surgical Assist Device For Ent Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4460
Definition A Cooperative Powered Surgical Assist Device For Ear, Nose, And Throat (ent) Surgery Is A Device That Facilitates Ent Surgical Procedures, Including Instrument Placement. The Device Works In Conjunction With The Surgeon's Movements To Assist With Precise And Stable Positioning Of An Instrument While Maintaining The Surgeon’s Direct Physical Control Of The Instrument.
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 Ear, Nose, Throat devices follow this clearance model.