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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 the device name listed in this FDA 510(k) record. The listed applicant is Embecta Medical I, LLC. It received FDA 510(k) clearance on 2024-08-30 under 510(k) 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. The listed applicant is Embecta Medical I, LLC. The 510(k) number is K234027.

When did embecta Insulin Delivery System receive FDA 510(k) clearance?

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

Who is the listed applicant for embecta Insulin Delivery System?

The FDA 510(k) record lists Embecta Medical I, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: QFG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261672twiist Automated Insulin Delivery (AID) SystemDeka Research and DevelopmentK253976iLet ACE PumpBeta Bionics, Inc.K253743MiniMed Flex pumpMedtronic Minimed, Inc.K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)Medtronic Minimed, Inc.K253074Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc.K252770iLet ACE PumpBeta Bionics, 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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