# K250663: Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent

- Pathway: 510(k) (Special)
- Applicant: Taewoong Medical Co., Ltd.
- Decided: Mar 31, 2025 after 26 days
- Product code: MUM (Stent, Metallic, Expandable, Duodenal)
- 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: 7 generations back to K000281 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223067: Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent, Taewoong Medical Co., Ltd. (2023) Summary page 5.

## Indications for use
Niti-S Duodenal Comfort Stent is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms. Niti-S Colonic Comfort Stent is indicated for the palliative treatment of colorectal strictures produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

Source page: https://510kreport.com/device/K250663
Methodology: https://510kreport.com/methodology