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FDA 510(k)

Disposable Automatically Retractable Safety Syringes (with detachable needle)

K-Number: K222452 · 2022-11-23

ApplicantShantou Wealy Medical Instrument Co.,Ltd
Decision Date2022-11-23
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Automatically Retractable Safety Syringes (with detachable needle) is a medical device manufactured by Shantou Wealy Medical Instrument Co.,Ltd. It received FDA 510(k) clearance on 2022-11-23 under approval number K222452. 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 Disposable Automatically Retractable Safety Syringes (with detachable needle)?

Disposable Automatically Retractable Safety Syringes (with detachable needle) is a medical device that received FDA 510(k) clearance on 2022-11-23. It is manufactured by Shantou Wealy Medical Instrument Co.,Ltd. The 510(k) number is K222452.

When was Disposable Automatically Retractable Safety Syringes (with detachable needle) approved by the FDA?

Disposable Automatically Retractable Safety Syringes (with detachable needle) received FDA 510(k) clearance on 2022-11-23, under approval number K222452.

What company makes Disposable Automatically Retractable Safety Syringes (with detachable needle)?

Disposable Automatically Retractable Safety Syringes (with detachable needle) is manufactured by Shantou Wealy Medical Instrument Co.,Ltd.

What is the FDA product code for Disposable Automatically Retractable Safety Syringes (with detachable needle)?

The FDA product code for Disposable Automatically Retractable Safety Syringes (with detachable needle) is MEG.

Related Clinical Trials

NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine RECRUITING NCT06000540 Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects NOT_YET_RECRUITING NCT06204614 Drug Screening Using IMD in Bladder Cancer ENROLLING_BY_INVITATION NCT07228117 GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes RECRUITING NCT05231278 Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy 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 Shantou Wealy Medical Instrument Co.,Ltd

K203613ENFit Reusable Enteral Syringe K203410ENFit Disposable Enteral Syringe K210216Disposable Automatically Retractable Insulin Safety Syringe

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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