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FDA 510(k)

SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE

K-Number: K130212 · 2013-11-20

ApplicantWuxi Yushou Medical Applicances Co., Ltd.
Decision Date2013-11-20
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Wuxi Yushou Medical Applicances Co., Ltd.. It received FDA 510(k) clearance on 2013-11-20 under 510(k) number K130212. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE?

SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE is a medical device that received FDA 510(k) clearance on 2013-11-20. The listed applicant is Wuxi Yushou Medical Applicances Co., Ltd.. The 510(k) number is K130212.

When did SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE receive FDA 510(k) clearance?

SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE received FDA 510(k) clearance on 2013-11-20, under 510(k) number K130212.

Who is the listed applicant for SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE?

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

What is the FDA product code for SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE?

The FDA product code for SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE is FMI.

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.

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Other records listing Wuxi Yushou Medical Applicances Co., Ltd. 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.

K130230STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLESK053519SAFETY SYRINGE

Related Devices (Code: FMI)

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.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

Official Source

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