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FDA 510(k)

WTF SECURA SYRINGE AND NEEDLE

K-Number: K132120 · 2013-12-12

ApplicantBeijing Wantefu Medical Apparatus Co., Ltd.
Decision Date2013-12-12
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

WTF SECURA SYRINGE AND NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Wantefu Medical Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2013-12-12 under 510(k) number K132120. 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 WTF SECURA SYRINGE AND NEEDLE?

WTF SECURA SYRINGE AND NEEDLE is a medical device that received FDA 510(k) clearance on 2013-12-12. The listed applicant is Beijing Wantefu Medical Apparatus Co., Ltd.. The 510(k) number is K132120.

When did WTF SECURA SYRINGE AND NEEDLE receive FDA 510(k) clearance?

WTF SECURA SYRINGE AND NEEDLE received FDA 510(k) clearance on 2013-12-12, under 510(k) number K132120.

Who is the listed applicant for WTF SECURA SYRINGE AND NEEDLE?

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

What is the FDA product code for WTF SECURA SYRINGE AND NEEDLE?

The FDA product code for WTF SECURA SYRINGE AND NEEDLE is FMF.

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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.

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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