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FDA 510(k)

EndoflipTM 300

K-Number: K223705 · 2023-04-14

ApplicantCovidien, LLC
Decision Date2023-04-14
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EndoflipTM 300 is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2023-04-14 under approval number K223705. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndoflipTM 300?

EndoflipTM 300 is a medical device that received FDA 510(k) clearance on 2023-04-14. It is manufactured by Covidien, LLC. The 510(k) number is K223705.

When was EndoflipTM 300 approved by the FDA?

EndoflipTM 300 received FDA 510(k) clearance on 2023-04-14, under approval number K223705.

What company makes EndoflipTM 300?

EndoflipTM 300 is manufactured by Covidien, LLC.

What is the FDA product code for EndoflipTM 300?

The FDA product code for EndoflipTM 300 is FFX.

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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.