INUMI Flex Needle
K-Number: K233884 · 2024-05-22
ApplicantGalvanize Therapeutics, Inc.
Decision Date2024-05-22
Product CodeOAB
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
INUMI Flex Needle is a medical device manufactured by Galvanize Therapeutics, Inc.. It received FDA 510(k) clearance on 2024-05-22 under approval number K233884. The device is classified under product code OAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the INUMI Flex Needle?
INUMI Flex Needle is a medical device that received FDA 510(k) clearance on 2024-05-22. It is manufactured by Galvanize Therapeutics, Inc.. The 510(k) number is K233884.
When was INUMI Flex Needle approved by the FDA?
INUMI Flex Needle received FDA 510(k) clearance on 2024-05-22, under approval number K233884.
What company makes INUMI Flex Needle?
INUMI Flex Needle is manufactured by Galvanize Therapeutics, Inc..
What is the FDA product code for INUMI Flex Needle?
The FDA product code for INUMI Flex Needle is OAB.
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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.