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FDA 510(k)

Ablation Confirmation

K-Number: K171022 · 2017-05-09

ApplicantNeuwave Medical, Inc.
Decision Date2017-05-09
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ablation Confirmation is the device name listed in this FDA 510(k) record. The listed applicant is Neuwave Medical, Inc.. It received FDA 510(k) clearance on 2017-05-09 under 510(k) number K171022. 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 2017-05-09. The listed applicant is Neuwave Medical, Inc.. The 510(k) number is K171022.

When did Ablation Confirmation receive FDA 510(k) clearance?

Ablation Confirmation received FDA 510(k) clearance on 2017-05-09, under 510(k) number K171022.

Who is the listed applicant for Ablation Confirmation?

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

What is the FDA product code for Ablation Confirmation?

The FDA product code for Ablation Confirmation is JAK.

Other records listing Neuwave Medical, Inc. as applicant

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

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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