# K130906: Endoflip Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Crospon, Ltd.
- Decided: Jul 17, 2013 after 107 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 K934084 (1993). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 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.
- K102214: Endo Flip, Crospon, Ltd. (2010) Summary page 1.
- K120997: Barostat Software Option, Crospon, Ltd. (2012) Summary page 1.
- K983220: Stryker Infravision Esophageal Kit, Stryker Endoscopy (1999) Summary page 1.

## Indications for use
The EndoFLIP6 system is an endoscopically placed device indicated for use in patients finted with a gastric band. The device is intended to estimate the size of the stoma produced by the gastric band in a clinical setting. EndoFLIPS EF-620 catheter is indicated for use in measuring the size of a gastric sleeve created during bariatric surgery. It is suitable for diameter measurements for 22 to 60 French sleeves. The EndoFLIPO system is indicated for use in a clinical setting as a pressure and dimension measurement device and as an adjunct to other methods in the comprehensive evaluation of patients with symptoms consistent with esophageal sensory hypersensitivity. Note: EndoFLIP is a measurement system. It is not intended to perform a diagnostic test. The EF-325L has a locating LED used in conjunction with the shaft markings to locate the balloon midpoint.

Source page: https://510kreport.com/device/K130906
Methodology: https://510kreport.com/methodology