FDA 510(k)

Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use

Numéro K : K212857 · 2023-05-09

DemandeurJiangsu Zhiyu Medical Instrument Co, Ltd.

Date de décision2023-05-09

Code produitFMF

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Zhiyu Medical Instrument Co, Ltd.. It received FDA 510(k) clearance on 2023-05-09 under 510(k) number K212857. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use?

Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use is a medical device that received FDA 510(k) clearance on 2023-05-09. The listed applicant is Jiangsu Zhiyu Medical Instrument Co, Ltd.. The 510(k) number is K212857.

When did Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use receive FDA 510(k) clearance?

Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use received FDA 510(k) clearance on 2023-05-09, under 510(k) number K212857.

Who is the listed applicant for Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use?

The FDA 510(k) record lists Jiangsu Zhiyu Medical Instrument Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use?

The FDA product code for Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use is FMF.

Essais cliniques associés

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Dispositifs connexes (Code : FMF)

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC K253110Sol-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.

Source officielle

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