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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 the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2020-02-13 under 510(k) 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. The listed applicant is Covidien, LLC. The 510(k) number is K193232.

When did Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology receive FDA 510(k) clearance?

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

Who is the listed applicant for Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology?

The FDA 510(k) record lists Covidien, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

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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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