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 a medical device manufactured by Neuwave Medical, Inc.. It received FDA 510(k) clearance on 2024-04-04 under approval 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. It is manufactured by Neuwave Medical, Inc.. The 510(k) number is K232227.
When was ABLATE-IQ approved by the FDA?
ABLATE-IQ received FDA 510(k) clearance on 2024-04-04, under approval number K232227.
What company makes ABLATE-IQ?
ABLATE-IQ is manufactured by Neuwave Medical, Inc..
What is the FDA product code for ABLATE-IQ?
The FDA product code for ABLATE-IQ 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.