# K030769: Ultraflex Precision Colonic Stent

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jul 14, 2003 after 125 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
No predicates in its family tree.
31 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) C.R. Bard Memotherm Colorectal Stent: named in the summary without a submission number

## Most influential descendants
- K042065: Wallflex Enternal Colonic Stent and Anchor Lock Delivery System (2004), 29 descendants of its own
- K073266: Wallflex Partially Covered Esophageal Stent System (2008), 15 descendants of its own
- K091510: Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720, M00516730 (2009), 14 descendants of its own
- K062750: Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System, Models M00565010, M00565020, M00565030 (2006), 11 descendants of its own
- K060323: Ultraflex Precision Colonic Stent, Models M00557330, MO00557360, M00557380 (2006), 11 descendants of its own

## Indications for use
The Ultraflex Precision Colonic Stent is indicated for palliative treatment of colonic strictures in the descending colon, sigmoid colon and rectum caused by malignant neoplasms.

Source page: https://510kreport.com/device/K030769
Methodology: https://510kreport.com/methodology