FDA 510(k)

VIVAWAVE MICROWAVE ABLATION SYSTEM

K-Number: K053535 · 2006-04-27

Decision Date2006-04-27

Product CodeNEY

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

VIVAWAVE MICROWAVE ABLATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Valleylab. It received FDA 510(k) clearance on 2006-04-27 under 510(k) number K053535. 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 VIVAWAVE MICROWAVE ABLATION SYSTEM?

VIVAWAVE MICROWAVE ABLATION SYSTEM is a medical device that received FDA 510(k) clearance on 2006-04-27. The listed applicant is Valleylab. The 510(k) number is K053535.

When did VIVAWAVE MICROWAVE ABLATION SYSTEM receive FDA 510(k) clearance?

VIVAWAVE MICROWAVE ABLATION SYSTEM received FDA 510(k) clearance on 2006-04-27, under 510(k) number K053535.

Who is the listed applicant for VIVAWAVE MICROWAVE ABLATION SYSTEM?

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

What is the FDA product code for VIVAWAVE MICROWAVE ABLATION SYSTEM?

The FDA product code for VIVAWAVE MICROWAVE ABLATION SYSTEM 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.