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FDA 510(k)

Emprint SX Ablation Platform and Accessories

K-Number: K171358 · 2017-09-01

ApplicantCoviden, LLC
Decision Date2017-09-01
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Emprint SX Ablation Platform and Accessories is a medical device manufactured by Coviden, LLC. It received FDA 510(k) clearance on 2017-09-01 under approval number K171358. 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 SX Ablation Platform and Accessories?

Emprint SX Ablation Platform and Accessories is a medical device that received FDA 510(k) clearance on 2017-09-01. It is manufactured by Coviden, LLC. The 510(k) number is K171358.

When was Emprint SX Ablation Platform and Accessories approved by the FDA?

Emprint SX Ablation Platform and Accessories received FDA 510(k) clearance on 2017-09-01, under approval number K171358.

What company makes Emprint SX Ablation Platform and Accessories?

Emprint SX Ablation Platform and Accessories is manufactured by Coviden, LLC.

What is the FDA product code for Emprint SX Ablation Platform and Accessories?

The FDA product code for Emprint SX Ablation Platform and Accessories is NEY.

Related Clinical Trials

NCT05755399 Feasibility of Transcranial Focused Ultrasound to Measure Brain Tumor RECRUITING NCT03775980 CIRSE Emprint Microwave Ablation Registry COMPLETED

Related PubMed Literature

PMID: 41517921 Approval Lag for Ablation Catheters: A Comparative Analysis of Regulatory Timelines in the European Union, United States, and Japan. Journal of cardiovascular electrophysiology (2026)

Related Devices (Code: NEY)

K163105Emprint Ablation SystemCovidien, LLC K160141miraDry SystemMiramar Labs, Inc. K160936Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc. 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. K173756Certus 140 2.45GHz Ablation SystemNeuwave 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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