FDA.report

510(k) K223705

Device
EndoflipTM 300
Applicant
Covidien, LLC
510(k) number
K223705
Product code
FFX
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-14
Date received
2022-12-12
Regulation
876.1725
Classification name
System, Gastrointestinal Motility (Electrical)
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Liron Bar Yaakov
Address
3062 Bunkerhill Ln. Santa Clara CA US 95054 95054

FDA Registration Numbers

Source Documents

510(k) summary PDF

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