# K172128: EsoFLIP® ES-310 Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Crospon, Ltd.
- Decided: Nov 22, 2017 after 131 days
- Product code: PIE (Esophageal Dilator With Balloon And Electrode Sensors)
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K142000 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142000: Esoflip ES, Crospon, Ltd. (2014) Summary page 4.

## Indications for use
The EsoFLIP® ES-310 balloon catheter is indicated for use to dilate esophageal strictures due to esophageal surgery, primary gastro-esophageal reflux and radiation therapy. Note: The EsoFLIP® ES-310 balloon catheter is to be used only with the EndoFLIP® system.

Source page: https://510kreport.com/device/K172128
Methodology: https://510kreport.com/methodology