EndoflipTM 300 System
FDA 510(k) K231861 · Covidien, LLC
510(k) numberK231861
Submission
- Device name
- EndoflipTM 300 System
- Applicant
- Covidien, LLC
Santa Clara, CA, US - Received
- June 23, 2023
- Decision date
- July 21, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 System cleared by the FDA?
EndoflipTM 300 System (K231861) received a 510(k) decision of Substantially Equivalent on July 21, 2023, 28 days after the submission was received.
What is the product code of K231861?
The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.