Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K193232 · 2020-02-13

ApplicantCovidien, LLC
Decision Date2020-02-13
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2020-02-13 under approval number K193232. 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 SX Ablation Platform with Thermosphere Technology?

Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology is a medical device that received FDA 510(k) clearance on 2020-02-13. It is manufactured by Covidien, LLC. The 510(k) number is K193232.

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

Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology received FDA 510(k) clearance on 2020-02-13, under approval number K193232.

What company makes Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology?

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

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

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

Related Clinical Trials

NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT05321134 Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery RECRUITING NCT06762717 FARAPULSE™ Pulsed Field Ablation System RECRUITING NCT06170606 POLARx Post Approval Study (POLARx PAS) ACTIVE_NOT_RECRUITING NCT07612332 Non-Immersive Virtual Reality for Gait and Balance Training in Children With Cerebral Palsy NOT_YET_RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING

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: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Covidien, LLC

K163105Emprint Ablation System K163098Tri-Staple 2.0 Intelligent Cartridge K160290Valleylab REM Polyhesive Infant Patient Return Electrode K160654GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) K152794Cytosponge Cell Collection Device K160360Barrx FLEX RFA Energy Generator

View all 57 devices →

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.

↑