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FDA 510(k)

APEXUM ABLATOR

K-Number: K082325 · 2009-04-21

ApplicantApexum , Ltd.
Decision Date2009-04-21
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

APEXUM ABLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Apexum , Ltd.. It received FDA 510(k) clearance on 2009-04-21 under 510(k) number K082325. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APEXUM ABLATOR?

APEXUM ABLATOR is a medical device that received FDA 510(k) clearance on 2009-04-21. The listed applicant is Apexum , Ltd.. The 510(k) number is K082325.

When did APEXUM ABLATOR receive FDA 510(k) clearance?

APEXUM ABLATOR received FDA 510(k) clearance on 2009-04-21, under 510(k) number K082325.

Who is the listed applicant for APEXUM ABLATOR?

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

What is the FDA product code for APEXUM ABLATOR?

The FDA product code for APEXUM ABLATOR is EKX.

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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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