Decision Date2018-07-11
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Aspire Introducer Needle is a medical device manufactured by Aspire Bariatrics, Inc.. It received FDA 510(k) clearance on 2018-07-11 under approval number K180725. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Aspire Introducer Needle?
Aspire Introducer Needle is a medical device that received FDA 510(k) clearance on 2018-07-11. It is manufactured by Aspire Bariatrics, Inc.. The 510(k) number is K180725.
When was Aspire Introducer Needle approved by the FDA?
Aspire Introducer Needle received FDA 510(k) clearance on 2018-07-11, under approval number K180725.
What company makes Aspire Introducer Needle?
Aspire Introducer Needle is manufactured by Aspire Bariatrics, Inc..
What is the FDA product code for Aspire Introducer Needle?
The FDA product code for Aspire Introducer Needle is KNT.
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Official Source
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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.