# K160725: EndoFLIP

- Pathway: 510(k) (Traditional)
- Applicant: Crospon, Ltd.
- Decided: May 1, 2016 after 46 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: 3 generations back to K991288 (1999). 4 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991288: Distender Series II Barostat, G & J Electronics, Inc. (1999) Summary page 4.
- K120997: Barostat Software Option, Crospon, Ltd. (2012) Summary page 4.
- K092850: Endoflip, Crospon, Ltd. (2009) Summary page 4.

## Most influential descendants
- K183072: EndoFLIP System (2019), 2 descendants of its own
- K223705: EndoflipTM 300 (2023), 1 descendant of its own
- K231861: EndoflipTM 300 System (2023), 0 descendants of its own
- K170833: EndoFLIP® System with FLIP Topography module (2017), 0 descendants of its own

## Indications for use
The EndoFLIP® System is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters. 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. The EF-325 series of catheters can make pressure and dimensional measurements in the esophagus, pylorus, and anal sphincters; whereas the BF-325 series and EF-825 catheters can make dimensional measurements in the esophagus, pylorus, and anal sphincters. The EF-620 catheter can make dimensional measurements in the esophagus. Other indications for use include: » To estimate the size of a stoma produced by a gastric band (all EndoFLIP catheters) * For use as an adjunct to a bougie for measuring the size of a gastric sleeve created during bariatric surgery, where it is suitable for diameter measurements for 22 to 60Fr sleeves (EF-620 catheter)

Source page: https://510kreport.com/device/K160725
Methodology: https://510kreport.com/methodology