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FDA 510(k)

HWJECT Auto-disable syringe

K-Number: K234024 · 2024-03-19

ApplicantAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Decision Date2024-03-19
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HWJECT Auto-disable syringe is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2024-03-19 under 510(k) number K234024. 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 HWJECT Auto-disable syringe?

HWJECT Auto-disable syringe is a medical device that received FDA 510(k) clearance on 2024-03-19. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. The 510(k) number is K234024.

When did HWJECT Auto-disable syringe receive FDA 510(k) clearance?

HWJECT Auto-disable syringe received FDA 510(k) clearance on 2024-03-19, under 510(k) number K234024.

Who is the listed applicant for HWJECT Auto-disable syringe?

The FDA 510(k) record lists Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HWJECT Auto-disable syringe?

The FDA product code for HWJECT Auto-disable syringe is FMF.

Other records listing Anhui Hongyu Wuzhou Medical Manufacturer 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.

K230061Insulin SyringeK230043Insulin Pen NeedleK223323Blood Collection Needle (with/without Needle Holder)K222124Sterile Hypodermic Syringe with/without Needle, Hypodermic NeedleK222141Safety Blood Collection Needle (Without Needle Holder)K220900Safety Blood Collection Needles with/without Needle Holder

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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.

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

View on FDA Database →

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

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