SteriCap Safety Needle; VitreJect Safety Needle
K-Number: K233343 · 2023-11-27
ApplicantOcuject, LLC
Decision Date2023-11-27
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
SteriCap Safety Needle; VitreJect Safety Needle is a medical device manufactured by Ocuject, LLC. It received FDA 510(k) clearance on 2023-11-27 under approval number K233343. 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 SteriCap Safety Needle; VitreJect Safety Needle?
SteriCap Safety Needle; VitreJect Safety Needle is a medical device that received FDA 510(k) clearance on 2023-11-27. It is manufactured by Ocuject, LLC. The 510(k) number is K233343.
When was SteriCap Safety Needle; VitreJect Safety Needle approved by the FDA?
SteriCap Safety Needle; VitreJect Safety Needle received FDA 510(k) clearance on 2023-11-27, under approval number K233343.
What company makes SteriCap Safety Needle; VitreJect Safety Needle?
SteriCap Safety Needle; VitreJect Safety Needle is manufactured by Ocuject, LLC.
What is the FDA product code for SteriCap Safety Needle; VitreJect Safety Needle?
The FDA product code for SteriCap Safety Needle; VitreJect Safety 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.