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FDA 510(k)

Retractable Safety Insulin Syringe

K-Number: K193022 · 2020-07-20

ApplicantJiangsu Caina Medical Co.,Ltd
Decision Date2020-07-20
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Retractable Safety Insulin Syringe is a medical device manufactured by Jiangsu Caina Medical Co.,Ltd. It received FDA 510(k) clearance on 2020-07-20 under approval number K193022. 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 Retractable Safety Insulin Syringe?

Retractable Safety Insulin Syringe is a medical device that received FDA 510(k) clearance on 2020-07-20. It is manufactured by Jiangsu Caina Medical Co.,Ltd. The 510(k) number is K193022.

When was Retractable Safety Insulin Syringe approved by the FDA?

Retractable Safety Insulin Syringe received FDA 510(k) clearance on 2020-07-20, under approval number K193022.

What company makes Retractable Safety Insulin Syringe?

Retractable Safety Insulin Syringe is manufactured by Jiangsu Caina Medical Co.,Ltd.

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

The FDA product code for Retractable Safety Insulin 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 NCT07602036 Type 2 Diabetes and Pregnancy a Single-arm Interventional Study NOT_YET_RECRUITING NCT05785832 A Randomized Trial Evaluating Control-IQ+ Technology in Adults With Type 2 Diabetes COMPLETED

Other Devices by Jiangsu Caina Medical Co.,Ltd

K181374NRFit Syringe K172938Disposable Sterile Needle K191490Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe K190502ENFit Oral / Enteral Syringe K200027Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter K193526Syringe with safety needle, Safety needle

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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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