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FDA 510(k)

Disposable Automatically Retractable Insulin Safety Syringe

K-Number: K210216 · 2022-03-04

ApplicantShantou Wealy Medical Instrument Co.,Ltd
Decision Date2022-03-04
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Automatically Retractable Insulin Safety Syringe is a medical device manufactured by Shantou Wealy Medical Instrument Co.,Ltd. It received FDA 510(k) clearance on 2022-03-04 under approval number K210216. 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 Insulin Safety Syringe?

Disposable Automatically Retractable Insulin Safety Syringe is a medical device that received FDA 510(k) clearance on 2022-03-04. It is manufactured by Shantou Wealy Medical Instrument Co.,Ltd. The 510(k) number is K210216.

When was Disposable Automatically Retractable Insulin Safety Syringe approved by the FDA?

Disposable Automatically Retractable Insulin Safety Syringe received FDA 510(k) clearance on 2022-03-04, under approval number K210216.

What company makes Disposable Automatically Retractable Insulin Safety Syringe?

Disposable Automatically Retractable Insulin Safety Syringe is manufactured by Shantou Wealy Medical Instrument Co.,Ltd.

What is the FDA product code for Disposable Automatically Retractable Insulin Safety Syringe?

The FDA product code for Disposable Automatically Retractable Insulin Safety Syringe is MEG.

Related Clinical Trials

NCT07599982 Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes RECRUITING NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT06728059 Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm COMPLETED NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING NCT07284511 A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar RECRUITING NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine RECRUITING

Other Devices by Shantou Wealy Medical Instrument Co.,Ltd

K203613ENFit Reusable Enteral Syringe K203410ENFit Disposable Enteral Syringe K222452Disposable Automatically Retractable Safety Syringes (with detachable needle)

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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