# K163495: AdvanCE capsule endoscope delivery device

- Pathway: 510(k) (Traditional)
- Applicant: United States Endoscopy Group, Inc.
- Decided: Mar 10, 2017 after 87 days
- Product code: NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule)
- Device class: 2
- Regulation: 21 CFR 876.1300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K252480: CE Deliver (DLV) (2025), 0 descendants of its own

## Indications for use
The disposable AdvanCE® capsule endoscope delivery device is a 2.5 mm single sheathed device indicated for transendoscopic delivery of Capsules (with the dimensions of 10.5mm — 11.5mm in diameter and 23.5mm — 26.5mm in length), to the stomach or duodenum. This device is intended for patients who are either unable to swallow the capsule, or unable to pass the capsule beyond the pylorus in sufficient time to complete the desired diagnostic evaluation.

Source page: https://510kreport.com/device/K163495
Methodology: https://510kreport.com/methodology