Cleared Traditional

K192406 - AveCure BT Microwave Ablation System

K192406 is the FDA 510(k) clearance for AveCure BT Microwave Ablation System by Medwaves, Inc.. It is a Class 2 Orthopedic device (product code NEY) cleared through the Traditional 510(k) pathway after a 448-day FDA review.

K192406 · Medwaves, Inc. · Orthopedic device
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Nov 2020
Decision
448d
Days
Class 2
Risk

K192406 is an FDA 510(k) clearance for the AveCure BT Microwave Ablation System. Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Medwaves, Inc. (San Diego, US). The FDA issued a Cleared decision on November 25, 2020 after a review of 448 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4400 - the FDA orthopedic device regulatory 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 Orthopedic submissions.

View all Medwaves, Inc. devices

Submission Details

510(k) Number K192406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2019
Decision Date November 25, 2020
Days to Decision 448 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
326d slower than avg
Panel avg: 122d · This submission: 448d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NEY System, Ablation, Microwave And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 Orthopedic devices follow this clearance model.

Regulatory Peers - NEY System, Ablation, Microwave And Accessories

All 39
Devices cleared under the same product code (NEY) and FDA review panel - the closest regulatory comparables to K192406.
Microwave Therapeutic System
K201262 · Nanjing Eco Microwave System Co., Ltd. · Jul 2021
ABI Instrument, Creo Electrosurgical System
K200298 · Creo Medical, Ltd. · Jan 2021
Emprint SX Ablation Platform with Thermosphere Technology
K203303 · Covidien, LLC · Dec 2020
NEUWAVE Microwave Ablation System and Accessories
K200081 · Neuwave Medical, Inc. · Nov 2020
NP1 Instrument, Creo Electrosurgical System
K200003 · Creo Medical, Ltd. · Oct 2020
Emprint Ablation System with Thermosphere Technology
K200796 · Covidien, LLC · Aug 2020