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FDA 510(k)

Omnifix Low Dead Space Luer Lock Syringe

K-Number: K193101 · 2020-03-05

ApplicantB.Braun Medical, Inc.
Decision Date2020-03-05
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Omnifix Low Dead Space Luer Lock Syringe is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2020-03-05 under 510(k) number K193101. 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 Omnifix Low Dead Space Luer Lock Syringe?

Omnifix Low Dead Space Luer Lock Syringe is a medical device that received FDA 510(k) clearance on 2020-03-05. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K193101.

When did Omnifix Low Dead Space Luer Lock Syringe receive FDA 510(k) clearance?

Omnifix Low Dead Space Luer Lock Syringe received FDA 510(k) clearance on 2020-03-05, under 510(k) number K193101.

Who is the listed applicant for Omnifix Low Dead Space Luer Lock Syringe?

The FDA 510(k) record lists B.Braun Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Omnifix Low Dead Space Luer Lock Syringe?

The FDA product code for Omnifix Low Dead Space Luer Lock Syringe is FMF.

Related Clinical Trials

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NCT07585188Neonatal Catheter Lock for Infection PreventionNOT_YET_RECRUITING

Other records listing B.Braun Medical, Inc. as applicant

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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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