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FDA 510(k)

YI XIN STERILE SYRINGE FOR SINGLE USE

K-Number: K050999 · 2005-09-02

ApplicantJiangxi Sanxin (Eversincere) Medical Devices Group
Decision Date2005-09-02
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

YI XIN STERILE SYRINGE FOR SINGLE USE is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Sanxin (Eversincere) Medical Devices Group. It received FDA 510(k) clearance on 2005-09-02 under 510(k) number K050999. 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 YI XIN STERILE SYRINGE FOR SINGLE USE?

YI XIN STERILE SYRINGE FOR SINGLE USE is a medical device that received FDA 510(k) clearance on 2005-09-02. The listed applicant is Jiangxi Sanxin (Eversincere) Medical Devices Group. The 510(k) number is K050999.

When did YI XIN STERILE SYRINGE FOR SINGLE USE receive FDA 510(k) clearance?

YI XIN STERILE SYRINGE FOR SINGLE USE received FDA 510(k) clearance on 2005-09-02, under 510(k) number K050999.

Who is the listed applicant for YI XIN STERILE SYRINGE FOR SINGLE USE?

The FDA 510(k) record lists Jiangxi Sanxin (Eversincere) Medical Devices Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for YI XIN STERILE SYRINGE FOR SINGLE USE?

The FDA product code for YI XIN STERILE SYRINGE FOR SINGLE USE is FMF.

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Other records listing Jiangxi Sanxin (Eversincere) Medical Devices Group 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.

K042102YIXIN SAFETY SYRINGE

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-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, 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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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