# K231861: EndoflipTM 300 System

- Pathway: 510(k) (Special)
- Applicant: Covidien, LLC
- Decided: Jul 21, 2023 after 28 days
- Product code: FFX (System, Gastrointestinal Motility (Electrical))
- Device class: 2
- Regulation: 21 CFR 876.1725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K991288 (1999). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223705: EndoflipTM 300, Covidien, LLC (2023) Summary page 4.

## Indications for use
The Endoflip™ 300 System is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters in adults and to measure pressure and dimensions in the esophagus, in patients from five years of age. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders.

Source page: https://510kreport.com/device/K231861
Methodology: https://510kreport.com/methodology