# K060323: Ultraflex Precision Colonic Stent, Models M00557330, MO00557360, M00557380

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: May 12, 2006 after 92 days
- Product code: MQR (Stent, Colonic, Metallic, Expandable)
- Device class: 2
- Regulation: 21 CFR 878.3610
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000281 (2000). 2 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030769: Ultraflex Precision Colonic Stent, Boston Scientific Corp (2003) Summary page 1.
- K000281: Wallstent Enternal Prosthesis, Boston Scientific Corp (2000) Summary page 1.

## Most influential descendants
- K061877: Wallflex Enteral Colonic Stent with Anchor Lock Delivery System (2006), 10 descendants of its own
- K180180: HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) (2018), 4 descendants of its own
- K183616: HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) (2019), 3 descendants of its own
- K113510: Evolution Colonic Stent System (2012), 3 descendants of its own
- K190141: HANAROSTENT LowAx Colon/Rectum (NNN) (2019), 2 descendants of its own

## Recalls of this device
- Jul 15, 2010 · Not classified · Z-2331-2010: Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment.

## Indications for use
The UltraflexTM PrecisionTM Colonic Stent is indicated for palliative treatment of colonic strictures in the descending colon, sigmoid colon and rectum caused by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

Source page: https://510kreport.com/device/K060323
Methodology: https://510kreport.com/methodology