# K092850: Endoflip

- Pathway: 510(k) (Traditional)
- Applicant: Crospon, Ltd.
- Decided: Dec 15, 2009 after 90 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: 1 generation back to K991288 (1999). 2 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 12 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 1.
- K012232: Insight, Model S980000, Sandhill Scientific, Inc. (2002) Summary page 1.

## Most influential descendants
- K120997: Barostat Software Option (2012), 7 descendants of its own
- K160725: EndoFLIP (2016), 4 descendants of its own
- K183072: EndoFLIP System (2019), 2 descendants of its own
- K223705: EndoflipTM 300 (2023), 1 descendant of its own
- K102214: Endo Flip (2010), 1 descendant of its own

## Indications for use
The EndoFLIP® system is an endoscopically-placed device indicated for use in patients fitted with a gastric band. The device is intended to estimate the size of the stoma produced by the gastric band in a clinical setting.

Source page: https://510kreport.com/device/K092850
Methodology: https://510kreport.com/methodology