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FDA 510(k)

Ablation Confirmation

K-Number: K161285 · 2016-06-29

ApplicantNeuwave Medical, Inc.
Decision Date2016-06-29
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ablation Confirmation is a medical device manufactured by Neuwave Medical, Inc.. It received FDA 510(k) clearance on 2016-06-29 under approval number K161285. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ablation Confirmation?

Ablation Confirmation is a medical device that received FDA 510(k) clearance on 2016-06-29. It is manufactured by Neuwave Medical, Inc.. The 510(k) number is K161285.

When was Ablation Confirmation approved by the FDA?

Ablation Confirmation received FDA 510(k) clearance on 2016-06-29, under approval number K161285.

What company makes Ablation Confirmation?

Ablation Confirmation is manufactured by Neuwave Medical, Inc..

What is the FDA product code for Ablation Confirmation?

The FDA product code for Ablation Confirmation is JAK.

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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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