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FDA 510(k)

BD Texium™ Needle-Free Syringe

K-Number: K231888 · 2023-09-25

ApplicantCare Fusion
Decision Date2023-09-25
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD Texium™ Needle-Free Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Care Fusion. It received FDA 510(k) clearance on 2023-09-25 under 510(k) number K231888. 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 BD Texium™ Needle-Free Syringe?

BD Texium™ Needle-Free Syringe is a medical device that received FDA 510(k) clearance on 2023-09-25. The listed applicant is Care Fusion. The 510(k) number is K231888.

When did BD Texium™ Needle-Free Syringe receive FDA 510(k) clearance?

BD Texium™ Needle-Free Syringe received FDA 510(k) clearance on 2023-09-25, under 510(k) number K231888.

Who is the listed applicant for BD Texium™ Needle-Free Syringe?

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

What is the FDA product code for BD Texium™ Needle-Free Syringe?

The FDA product code for BD Texium™ Needle-Free Syringe is FMF.

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.

NCT07498621Assessment of Maxillary Local Anesthesia Infiltration Using Needle-free Jet vs Conventional Syringe in Tooth ExtractionCOMPLETEDNCT07548892Comparison of Needle-Free Injection and Conventional Syringe for Tooth Extractions in ChildrenNOT_YET_RECRUITINGNCT07581249This Study Evaluate the Patient Response to Jet Injection, Pain and Satisfaction Compared to Conventional Method of Local Anasthesia Especially in Maxillary TeethCOMPLETED

Other records listing Care Fusion 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.

K233021BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access DeviceK221327BD Alaris™ Pump Infusion SetsK221319BD Alaris™ Pump Epidural Infusion SetK223101BD Secondary Infusion SetK223088BD SmartSite™ Needle-Free ConnectorK223076BD Texium™ Closed Male Luer

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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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