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FDA 510(k)

embecta Insulin Delivery System

K-Number: K234027 · 2024-08-30

ApplicantEmbecta Medical I, LLC
Decision Date2024-08-30
Product CodeQFG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

embecta Insulin Delivery System is a medical device manufactured by Embecta Medical I, LLC. It received FDA 510(k) clearance on 2024-08-30 under approval number K234027. The device is classified under product code QFG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the embecta Insulin Delivery System?

embecta Insulin Delivery System is a medical device that received FDA 510(k) clearance on 2024-08-30. It is manufactured by Embecta Medical I, LLC. The 510(k) number is K234027.

When was embecta Insulin Delivery System approved by the FDA?

embecta Insulin Delivery System received FDA 510(k) clearance on 2024-08-30, under approval number K234027.

What company makes embecta Insulin Delivery System?

embecta Insulin Delivery System is manufactured by Embecta Medical I, LLC.

What is the FDA product code for embecta Insulin Delivery System?

The FDA product code for embecta Insulin Delivery System is QFG.

Related Clinical Trials

NCT07039942 French Prospective Multicentric Study in Real World 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 NCT07458243 A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population NOT_YET_RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 38767890 Strengthening the use of artificial intelligence within healthcare delivery organizations: balancing regulatory compliance and patient safety. Journal of the American Medical Informatics Association : JAMIA (2024) PMID: 37873612 A European regulatory pathway for Tidepool loop following clearance in the United States? Diabetic medicine : a journal of the British Diabetic Association (2024)

Related Devices (Code: QFG)

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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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