Cleared Traditional

K233466 - Edison System (FDA 510(k) Clearance)

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

K233466 · HistoSonics, Inc. · General & Plastic Surgery device
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Mar 2024
Decision
141d
Days
Class 2
Risk

K233466 is an FDA 510(k) clearance 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 Cleared decision on March 13, 2024 after a review of 141 days - within the typical 510(k) review window.

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 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.

View all HistoSonics, Inc. devices

Submission Details

510(k) Number K233466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2023
Decision Date March 13, 2024
Days to Decision 141 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
27d slower than avg
Panel avg: 114d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.