# K102214: Endo Flip

- Pathway: 510(k) (Traditional)
- Applicant: Crospon, Ltd.
- Decided: Dec 16, 2010 after 132 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: 2 generations back to K991288 (1999). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092850: Endoflip, Crospon, Ltd. (2009) Summary page 1.

## Most influential descendants
- K130906: Endoflip Catheter (2013), 0 descendants of its own

## Indications for use
The EndoFLIP® EF-620 catheter is indicated for use as an adjunct to a bougie for measuring the size of a gastric sleeve created during bariatric surgery. It is suitable for diameter measurements for 22 to 60 French sleeves. The EF-620 catheter is to be used only with the EndoFlip System.

Source page: https://510kreport.com/device/K102214
Methodology: https://510kreport.com/methodology