VitreJect® Needle; OcuSafe® Needle
K-Number: K230959 · 2023-09-14
ApplicantOcuject, LLC
Decision Date2023-09-14
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
VitreJect® Needle; OcuSafe® Needle is a medical device manufactured by Ocuject, LLC. It received FDA 510(k) clearance on 2023-09-14 under approval number K230959. 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 VitreJect® Needle; OcuSafe® Needle?
VitreJect® Needle; OcuSafe® Needle is a medical device that received FDA 510(k) clearance on 2023-09-14. It is manufactured by Ocuject, LLC. The 510(k) number is K230959.
When was VitreJect® Needle; OcuSafe® Needle approved by the FDA?
VitreJect® Needle; OcuSafe® Needle received FDA 510(k) clearance on 2023-09-14, under approval number K230959.
What company makes VitreJect® Needle; OcuSafe® Needle?
VitreJect® Needle; OcuSafe® Needle is manufactured by Ocuject, LLC.
What is the FDA product code for VitreJect® Needle; OcuSafe® Needle?
The FDA product code for VitreJect® Needle; OcuSafe® Needle 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.