Not Cleared Direct

DEN150022 - Ultravision Visual Clearing System (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN150022 · Alesi Surgical, Ltd. · General Hospital
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Dec 2016
Decision
574d
Days
Class 2
Risk

DEN150022 is an FDA 510(k) submission (not cleared) for the Ultravision Visual Clearing System. Classified as Surgical Smoke Precipitator (product code PQM), Class II - Special Controls.

Submitted by Alesi Surgical, Ltd. (Caediff, GB). The FDA issued a Not Cleared (DENG) decision on December 20, 2016 after a review of 574 days.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.5050 - the FDA general hospital 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 574 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.

View all Alesi Surgical, Ltd. devices

Submission Details

510(k) Number DEN150022 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 26, 2015
Decision Date December 20, 2016
Days to Decision 574 days
Submission Type Direct
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
446d slower than avg
Panel avg: 128d · This submission: 574d
Pathway characteristics

Device Classification

Product Code PQM Surgical Smoke Precipitator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5050
Definition The Device Is Intended To Precipitate Surgical Smoke To Allow Surgeons Adequately Visualize Laparoscopic Surgeries In The Using Surgical Smoke/aerosolized Particulate Surgical Tools.
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 Hospital devices follow this clearance model.