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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Ocuject, LLC. It received FDA 510(k) clearance on 2023-11-27 under 510(k) 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. The listed applicant is Ocuject, LLC. The 510(k) number is K233343.

When did SteriCap Safety Needle; VitreJect Safety Needle receive FDA 510(k) clearance?

SteriCap Safety Needle; VitreJect Safety Needle received FDA 510(k) clearance on 2023-11-27, under 510(k) number K233343.

Who is the listed applicant for SteriCap Safety Needle; VitreJect Safety Needle?

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 Safety Needle; VitreJect Safety Needle?

The FDA product code for SteriCap Safety Needle; VitreJect Safety Needle is FMI.

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 NeedleK230959VitreJect® Needle; OcuSafe® NeedleK230372VitreJect SyringeK212544MiniLoad SyringeK212805SteriCap Mini Needle and Standard NeedlesK202432MiniLoad 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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