Cleared Traditional

K241902 - Edison System

K241902 is an FDA 510(k) clearance for Edison System, manufactured by HistoSonics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code QGM cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K241902 · HistoSonics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
121d
Days
Class 2
Risk

K241902 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 October 30, 2024 after a review of 121 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

FDA 510(k) Submission Details - K241902

510(k) Number K241902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2024
Decision Date October 30, 2024
Days to Decision 121 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
6d slower than avg
Panel avg: 115d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QGM Device Classification - Class 2, Special Controls

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.