Not Cleared Direct

DEN220087 - Edison System (FDA 510(k) Clearance)

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

DEN220087 · HistoSonics, Inc. · General & Plastic Surgery device
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Oct 2023
Decision
308d
Days
Class 2
Risk

DEN220087 is an FDA 510(k) submission (not cleared) for the Edison System. Classified as Focused Ultrasound System For Non-thermal, Mechanical Tissue Ablation (product code QGM), Class II - Special Controls.

Submitted by HistoSonics, Inc. (Plymouth, US). The FDA issued a Not Cleared (DENG) decision on October 6, 2023 after a review of 308 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4405 - the FDA general and plastic surgery 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 308 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 HistoSonics, Inc. devices

Submission Details

510(k) Number DEN220087 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 02, 2022
Decision Date October 06, 2023
Days to Decision 308 days
Submission Type Direct
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
194d slower than avg
Panel avg: 114d · This submission: 308d
Pathway characteristics

Device Classification

Product Code QGM Focused Ultrasound System For Non-thermal, Mechanical Tissue Ablation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4405
Definition This Device Uses Focused Ultrasound To Mechanically Ablate Soft Tissue. The Device Is Not Intended To Thermally Ablate Tissue.
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.