# K182910: Segmented Esophageal Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Tech (Nanjing) Co., Ltd.
- Decided: May 29, 2019 after 224 days
- Product code: ESW (Prosthesis, Esophageal)
- Device class: 2
- Regulation: 21 CFR 878.3610
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K925406 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072094: Choostent, M.I.Tech Co., Ltd. (2008) Summary page 4.

## Indications for use
The Segmented Esophageal Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic, or extrinsic malignant tumors only, and occlusion of concurrent esophageal fistula.

Source page: https://510kreport.com/device/K182910
Methodology: https://510kreport.com/methodology