IO Needle Safety Sheath
K-Number: K220890 · 2022-10-31
ApplicantActuated Medical, Inc.
Decision Date2022-10-31
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
IO Needle Safety Sheath is a medical device manufactured by Actuated Medical, Inc.. It received FDA 510(k) clearance on 2022-10-31 under approval number K220890. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the IO Needle Safety Sheath?
IO Needle Safety Sheath is a medical device that received FDA 510(k) clearance on 2022-10-31. It is manufactured by Actuated Medical, Inc.. The 510(k) number is K220890.
When was IO Needle Safety Sheath approved by the FDA?
IO Needle Safety Sheath received FDA 510(k) clearance on 2022-10-31, under approval number K220890.
What company makes IO Needle Safety Sheath?
IO Needle Safety Sheath is manufactured by Actuated Medical, Inc..
What is the FDA product code for IO Needle Safety Sheath?
The FDA product code for IO Needle Safety Sheath is FMI.
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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.