Cleared Traditional

EPICOR MEDICAL ABLATION SYSTEM (K022894) - FDA 510(k) Clearance

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

K022894 · Epicor Medical, Inc. · General & Plastic Surgery device
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Feb 2004
Decision
541d
Days
Class 2
Risk

K022894 is an FDA 510(k) clearance for the EPICOR MEDICAL ABLATION SYSTEM. Classified as System, Ablation, Ultrasound And Accessories (product code NTB), Class II - Special Controls.

Submitted by Epicor Medical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on February 26, 2004 after a review of 541 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Epicor Medical, Inc. devices

Submission Details

510(k) Number K022894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2002
Decision Date February 26, 2004
Days to Decision 541 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
426d slower than avg
Panel avg: 115d · This submission: 541d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NTB System, Ablation, Ultrasound And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Intended For Use As A Surgical Tool For Coagulation And Ablation Of Soft Tissue. This Differs From The Description In The Regulation In That This Device Is Not Intended To Cut Tissue And This Device Uses High Intensity Ultrasound Energy Instead Of Electrosurgery Or Electrocautery.
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.