# K180180: HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)

- Pathway: 510(k) (Traditional)
- Applicant: M.I.Tech Co., Ltd.
- Decided: Nov 2, 2018 after 283 days
- Product code: MQR (Stent, Colonic, Metallic, Expandable)
- 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: 3 generations back to K000281 (2000). 6 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061877: Wallflex Enteral Colonic Stent with Anchor Lock Delivery System, Boston Scientific Corp (2006) Summary page 4.
- K062750: Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System, Models M00565010, M00565020, M00565030, Boston Scientific Corp (2006) Summary page 4.

## Most influential descendants
- K183616: HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) (2019), 3 descendants of its own
- K190141: HANAROSTENT LowAx Colon/Rectum (NNN) (2019), 2 descendants of its own
- K223067: Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent (2023), 1 descendant of its own
- K250663: Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent (2025), 0 descendants of its own

## Indications for use
The HANAROSTENT LowAxTM Colon/Rectum (NNN) 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 structures. The HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.

Source page: https://510kreport.com/device/K180180
Methodology: https://510kreport.com/methodology