Cleared Traditional

K200796 - Emprint Ablation System with Thermosphe...

K200796 is the FDA 510(k) clearance for Emprint Ablation System with Thermosphe... by Covidien, LLC. It is a Class 2 General & Plastic Surgery device (product code NEY) cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K200796 · Covidien, LLC · General & Plastic Surgery device
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Aug 2020
Decision
153d
Days
Class 2
Risk

K200796 is an FDA 510(k) clearance for the Emprint Ablation System with Thermosphere Technology. Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on August 26, 2020 after a review of 153 days - an extended review cycle.

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: 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 Covidien, LLC devices

Submission Details

510(k) Number K200796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2020
Decision Date August 26, 2020
Days to Decision 153 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
38d slower than avg
Panel avg: 115d · This submission: 153d
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 General & Plastic Surgery 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 K200796.
AveCure BT Microwave Ablation System
K192406 · Medwaves, Inc. · Nov 2020
NEUWAVE Microwave Ablation System and Accessories
K200081 · Neuwave Medical, Inc. · Nov 2020
NP1 Instrument, Creo Electrosurgical System
K200003 · Creo Medical, Ltd. · Oct 2020
HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)
K200061 · Galil Medical, Inc. · Jul 2020
Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology
K193232 · Covidien, LLC · Feb 2020
Microwave Ablation System
K183153 · Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Jul 2019