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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 the device name listed in this FDA 510(k) record. The listed applicant is Coviden, LLC. It received FDA 510(k) clearance on 2017-09-01 under 510(k) 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. The listed applicant is Coviden, LLC. The 510(k) number is K171358.

When did Emprint SX Ablation Platform and Accessories receive FDA 510(k) clearance?

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

Who is the listed applicant for Emprint SX Ablation Platform and Accessories?

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

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 Devices (Code: NEY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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