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FDA 510(k)

Disposable Pen Injector Assembly

K-Number: K240961 · 2024-08-15

ApplicantWuxi Nest Biotechnology Co., Ltd.
Decision Date2024-08-15
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Pen Injector Assembly is the device name listed in this FDA 510(k) record. The listed applicant is Wuxi Nest Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-08-15 under 510(k) number K240961. 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 Disposable Pen Injector Assembly?

Disposable Pen Injector Assembly is a medical device that received FDA 510(k) clearance on 2024-08-15. The listed applicant is Wuxi Nest Biotechnology Co., Ltd.. The 510(k) number is K240961.

When did Disposable Pen Injector Assembly receive FDA 510(k) clearance?

Disposable Pen Injector Assembly received FDA 510(k) clearance on 2024-08-15, under 510(k) number K240961.

Who is the listed applicant for Disposable Pen Injector Assembly?

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

What is the FDA product code for Disposable Pen Injector Assembly?

The FDA product code for Disposable Pen Injector Assembly is FMF.

Other records listing Wuxi Nest Biotechnology 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.

K240774Pen InjectorK211256Disposable Sampler Viral Transport MediaK210440Disposable Sampler Inactivated Transport Media, Nest ITM

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

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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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