SteriCap Mini Needle
K-Number: K183016 · 2019-05-07
ApplicantOcujet, LLC
Decision Date2019-05-07
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
SteriCap Mini Needle is a medical device manufactured by Ocujet, LLC. It received FDA 510(k) clearance on 2019-05-07 under approval number K183016. 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 Mini Needle?
SteriCap Mini Needle is a medical device that received FDA 510(k) clearance on 2019-05-07. It is manufactured by Ocujet, LLC. The 510(k) number is K183016.
When was SteriCap Mini Needle approved by the FDA?
SteriCap Mini Needle received FDA 510(k) clearance on 2019-05-07, under approval number K183016.
What company makes SteriCap Mini Needle?
SteriCap Mini Needle is manufactured by Ocujet, LLC.
What is the FDA product code for SteriCap Mini Needle?
The FDA product code for SteriCap Mini Needle is FMI.
Related Devices (Code: FMI)
K162516BD Pen NeedleBecton, Dickinson and Company
K160532Greiner HoldexGreiner Bio-One Na, Inc.
K160199Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc.
K151090CPL Insulin Pen NeedleCpl Co., Ltd.
K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc.
K153706Insulin Pen NeedleSteriLance Medical (Suzhou), Inc.
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.