Cleared Special

K193232 - Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology

K193232 is an FDA 510(k) clearance for Emprint Ablation System with Thermosphe..., manufactured by Covidien, LLC. The device is a Class 2 General & Plastic Surgery device with product code NEY cleared through the Special 510(k) pathway after a 80-day FDA review.

K193232 · Covidien, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
80d
Days
Class 2
Risk

K193232 is an FDA 510(k) clearance for the Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Pla.... 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 February 13, 2020 after a review of 80 days - a notably fast clearance 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K193232

510(k) Number K193232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2019
Decision Date February 13, 2020
Days to Decision 80 days
Submission Type Special
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
35d faster than avg
Panel avg: 115d · This submission: 80d
Pathway characteristics
Modification to existing cleared device.

NEY Device Classification - Class 2, Special Controls

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 68
Devices cleared under the same product code (NEY) and FDA review panel - the closest regulatory comparables to K193232.
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K193232 · Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology
Download PDF FDA Summary Covidien, LLC