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FDA 510(k)

Emprint Ablation System with Thermosphere Technology

K-Number: K200796 · 2020-08-26

ApplicantCovidien, LLC
Decision Date2020-08-26
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Emprint Ablation System with Thermosphere Technology is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2020-08-26 under approval number K200796. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Emprint Ablation System with Thermosphere Technology?

Emprint Ablation System with Thermosphere Technology is a medical device that received FDA 510(k) clearance on 2020-08-26. It is manufactured by Covidien, LLC. The 510(k) number is K200796.

When was Emprint Ablation System with Thermosphere Technology approved by the FDA?

Emprint Ablation System with Thermosphere Technology received FDA 510(k) clearance on 2020-08-26, under approval number K200796.

What company makes Emprint Ablation System with Thermosphere Technology?

Emprint Ablation System with Thermosphere Technology is manufactured by Covidien, LLC.

What is the FDA product code for Emprint Ablation System with Thermosphere Technology?

The FDA product code for Emprint Ablation System with Thermosphere Technology is NEY.

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Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025) PMID: 40837401 Mining and evaluation of security alert signals of neuroprotective agents based on the Jinan adverse event reporting system database: a retrospective study. Frontiers in pharmacology (2025) PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

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Related Devices (Code: NEY)

K163105Emprint Ablation SystemCovidien, LLC K160141miraDry SystemMiramar Labs, Inc. K160936Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc. K171358Emprint SX Ablation Platform and AccessoriesCoviden, LLC K162449Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)AngioDynamics, Inc. K163118FLEX Microwave Ablation System and AccessoriesNeuwave Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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