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FDA 510(k)

Safety Insulin Syringes

K-Number: K220061 · 2022-08-23

ApplicantBerpu Medical Technology Co., Ltd.
Decision Date2022-08-23
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Safety Insulin Syringes is a medical device manufactured by Berpu Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-08-23 under approval number K220061. 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 Safety Insulin Syringes?

Safety Insulin Syringes is a medical device that received FDA 510(k) clearance on 2022-08-23. It is manufactured by Berpu Medical Technology Co., Ltd.. The 510(k) number is K220061.

When was Safety Insulin Syringes approved by the FDA?

Safety Insulin Syringes received FDA 510(k) clearance on 2022-08-23, under approval number K220061.

What company makes Safety Insulin Syringes?

Safety Insulin Syringes is manufactured by Berpu Medical Technology Co., Ltd..

What is the FDA product code for Safety Insulin Syringes?

The FDA product code for Safety Insulin Syringes 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 Berpu Medical Technology Co., Ltd.

K162180Disposable Insulin Syringe K180417Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use K181447Safety insulin needle for single use K221045Insulin Syringes without needle K213158Syringe with permanently attached needle K213811Sterile Hypodermic Syringes for Single Use

View all 9 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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