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FDA 510(k)

ABLATE-IQ

K-Number: K232227 · 2024-04-04

ApplicantNeuwave Medical, Inc.
Decision Date2024-04-04
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ABLATE-IQ 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 2024-04-04 under 510(k) number K232227. 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 ABLATE-IQ?

ABLATE-IQ is a medical device that received FDA 510(k) clearance on 2024-04-04. The listed applicant is Neuwave Medical, Inc.. The 510(k) number is K232227.

When did ABLATE-IQ receive FDA 510(k) clearance?

ABLATE-IQ received FDA 510(k) clearance on 2024-04-04, under 510(k) number K232227.

Who is the listed applicant for ABLATE-IQ?

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 ABLATE-IQ?

The FDA product code for ABLATE-IQ 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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Related Devices (Code: JAK)

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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