# K223705: EndoflipTM 300

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Apr 14, 2023 after 123 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: 5 generations back to K991288 (1999). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183072: EndoFLIP System, Crospon, Ltd. (2019) Summary page 4.

## Most influential descendants
- K231861: EndoflipTM 300 System (2023), 0 descendants of its own

## 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 5 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/K223705
Methodology: https://510kreport.com/methodology