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FDA 510(k)

SteriCap Mini Needle and Standard Needles

K-Number: K212805 · 2021-09-30

ApplicantOcuject, LLC
Decision Date2021-09-30
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SteriCap Mini Needle and Standard Needles is a medical device manufactured by Ocuject, LLC. It received FDA 510(k) clearance on 2021-09-30 under approval number K212805. 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 and Standard Needles?

SteriCap Mini Needle and Standard Needles is a medical device that received FDA 510(k) clearance on 2021-09-30. It is manufactured by Ocuject, LLC. The 510(k) number is K212805.

When was SteriCap Mini Needle and Standard Needles approved by the FDA?

SteriCap Mini Needle and Standard Needles received FDA 510(k) clearance on 2021-09-30, under approval number K212805.

What company makes SteriCap Mini Needle and Standard Needles?

SteriCap Mini Needle and Standard Needles is manufactured by Ocuject, LLC.

What is the FDA product code for SteriCap Mini Needle and Standard Needles?

The FDA product code for SteriCap Mini Needle and Standard Needles is FMI.

Related Clinical Trials

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Other Devices by Ocuject, LLC

K170768Mini Needle K212544MiniLoad Syringe K202432MiniLoad Syringe K233343SteriCap Safety Needle; VitreJect Safety Needle K230959VitreJect® Needle; OcuSafe® Needle K230372VitreJect Syringe

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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.

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