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FDA 510(k)

MiniLoad Syringe

K-Number: K212544 · 2021-10-13

ApplicantOcuject, LLC
Decision Date2021-10-13
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MiniLoad Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Ocuject, LLC. It received FDA 510(k) clearance on 2021-10-13 under 510(k) number K212544. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MiniLoad Syringe?

MiniLoad Syringe is a medical device that received FDA 510(k) clearance on 2021-10-13. The listed applicant is Ocuject, LLC. The 510(k) number is K212544.

When did MiniLoad Syringe receive FDA 510(k) clearance?

MiniLoad Syringe received FDA 510(k) clearance on 2021-10-13, under 510(k) number K212544.

Who is the listed applicant for MiniLoad Syringe?

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 MiniLoad Syringe?

The FDA product code for MiniLoad Syringe is FMF.

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 SyringeK212805SteriCap Mini Needle and Standard NeedlesK202432MiniLoad Syringe

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Related Devices (Code: FMF)

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.

K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.

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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