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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 the device name listed in this FDA 510(k) record. The listed applicant is Ocuject, LLC. It received FDA 510(k) clearance on 2021-09-30 under 510(k) 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. The listed applicant is Ocuject, LLC. The 510(k) number is K212805.

When did SteriCap Mini Needle and Standard Needles receive FDA 510(k) clearance?

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

Who is the listed applicant for SteriCap Mini Needle and Standard Needles?

The FDA 510(k) record lists Ocuject, LLC as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT00102544Use of Tracking Devices to Locate Abnormalities During Invasive ProceduresENROLLING_BY_INVITATION

Other records listing Ocuject, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242956LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety NeedleK233343SteriCap Safety Needle; VitreJect Safety NeedleK230959VitreJect® Needle; OcuSafe® NeedleK230372VitreJect SyringeK212544MiniLoad SyringeK202432MiniLoad Syringe

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Related Devices (Code: FMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.K254273Verisafe Safety Sterile Needles (SSN)Promisemed Hangzhou Meditech Co., Ltd.

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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