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FDA 510(k)

Emprint SX Ablation Platform with Thermosphere Technology

K-Number: K203303 · 2020-12-17

ApplicantCovidien, LLC
Decision Date2020-12-17
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Emprint SX Ablation Platform with Thermosphere Technology is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2020-12-17 under approval number K203303. 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 with Thermosphere Technology?

Emprint SX Ablation Platform with Thermosphere Technology is a medical device that received FDA 510(k) clearance on 2020-12-17. It is manufactured by Covidien, LLC. The 510(k) number is K203303.

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

Emprint SX Ablation Platform with Thermosphere Technology received FDA 510(k) clearance on 2020-12-17, under approval number K203303.

What company makes Emprint SX Ablation Platform with Thermosphere Technology?

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

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

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

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Related Devices (Code: 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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