FDA 510(k)

Inessa System

K-Number: K230545 · 2023-12-20

Decision Date2023-12-20

Product CodeQFG

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Inessa System is the device name listed in this FDA 510(k) record. The listed applicant is Triple Jump Israel , Ltd.. It received FDA 510(k) clearance on 2023-12-20 under 510(k) number K230545. 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 Inessa System?

Inessa System is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is Triple Jump Israel , Ltd.. The 510(k) number is K230545.

When did Inessa System receive FDA 510(k) clearance?

Inessa System received FDA 510(k) clearance on 2023-12-20, under 510(k) number K230545.

Who is the listed applicant for Inessa System?

The FDA 510(k) record lists Triple Jump Israel , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Inessa System?

The FDA product code for Inessa 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 Development K253976iLet 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.