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510(k) K231861

EndoflipTM 300 System by Covidien, LLC — Product Code FFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2023
Date Received
June 23, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Gastrointestinal Motility (Electrical)
Device Class
Class II
Regulation Number
876.1725
Review Panel
GU
Submission Type

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