# K110531: Endoflip Ecd

- Pathway: 510(k) (Traditional)
- Applicant: Crospon, Ltd.
- Decided: Oct 6, 2011 after 224 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K993704 (2000). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100081: Enteroscopy Overtube, Model 00712140, United States Endoscopy Group, Inc. (2010) Summary page 1.
- K060923: Naviaid Bge Device, Model 21-001, Smart Medical Systems, Ltd. (2006) Summary page 1.

## Most influential descendants
- K150083: Sidecar External Working Channel (2015), 0 descendants of its own

## Indications for use
The EndoFLIP® EF-800 is an external channel for an endoscope (9.0 to 12.2 mm in diameter) used to aid in the insertion, advancement, and removal of endoscopic devices during endoscopic procedures The EndoFLIP® ECD is single patient use, disposable. Environments of use - Hospitals, Sub-acute care institutions, Surgery Centers, doctor's offices where endoscopic procedures may be performed.

Source page: https://510kreport.com/device/K110531
Methodology: https://510kreport.com/methodology