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FDA 510(k)

Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe

K-Number: K211555 · 2021-10-18

ApplicantAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Decision Date2021-10-18
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe is a medical device manufactured by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2021-10-18 under approval number K211555. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe?

Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe is a medical device that received FDA 510(k) clearance on 2021-10-18. It is manufactured by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. The 510(k) number is K211555.

When was Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe approved by the FDA?

Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe received FDA 510(k) clearance on 2021-10-18, under approval number K211555.

What company makes Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe?

Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe is manufactured by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd..

What is the FDA product code for Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe?

The FDA product code for Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe is MEG.

Related Clinical Trials

NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED NCT06000540 Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects NOT_YET_RECRUITING NCT06204614 Drug Screening Using IMD in Bladder Cancer ENROLLING_BY_INVITATION NCT07540806 Ultrasound-Guided Percutaneous Needle Tenotomy (PNT) vs Percutaneous Ultrasonic Needle Tenotomy (PUT) for Gluteal Tendinosis NOT_YET_RECRUITING NCT05231278 Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy COMPLETED NCT07581249 This Study Evaluate the Patient Response to Jet Injection, Pain and Satisfaction Compared to Conventional Method of Local Anasthesia Especially in Maxillary Teeth COMPLETED

Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

Other Devices by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

K190183Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe K202188Safety Blood Collection Sets for Single Use K222124Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle K222141Safety Blood Collection Needle (Without Needle Holder) K220900Safety Blood Collection Needles with/without Needle Holder K220083LDV((Low Dead Volume )Syringe

View all 12 devices →

Related Devices (Code: MEG)

K1620300.5ml Sol-Care Retractable Safety Syringe with Fixed NeedleSol-Millennium Medical, Inc. K152606Jeesung Safety Syringe and Single Use NeedlesJeesung Medical Co., Ltd. K152808U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd. K170651Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable NeedleYangzhou Medline Industry, Co., Ltd. K163162Sterile Hypodermic Safety Syringes for Single UseJiangxi Hongda Medical Equipment Group , Ltd. K163511NovaGuard SA Pro Safety SystemWest Pharmaceutical Services, Inc.

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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