# K962899: Ultraflex Diamond

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: May 20, 1997 after 299 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K925406 (1995). 1 ancestor in all.
22 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925406: Biliary Endoprostheses W/Unistep Delivery System, Schneider Intl., Ltd. (1995) Summary page 3.

## Most influential descendants
- K012883: Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex Tracheobronchial Stent System (2001), 21 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
- K121048: Ultraflex Tracheobronchial Stent System- Sterile Uncovered (2012), 5 descendants of its own
- K072094: Choostent (2008), 5 descendants of its own

## Indications for use
The Ultraflex™ Diamond Biliary Stent System is indicated for palliative treatment of patients with malignant biliary strictures.

Source page: https://510kreport.com/device/K962899
Methodology: https://510kreport.com/methodology