EndoflipTM 300
FDA 510(k) K223705 · Covidien, LLC
510(k) numberK223705
Submission
- Device name
- EndoflipTM 300
- Applicant
- Covidien, LLC
Santa Clara, CA, US - Received
- December 12, 2022
- Decision date
- April 14, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FFX – System, Gastrointestinal Motility (Electrical)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1725
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was EndoflipTM 300 cleared by the FDA?
EndoflipTM 300 (K223705) received a 510(k) decision of Substantially Equivalent on April 14, 2023, 123 days after the submission was received.
What is the product code of K223705?
The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.