# K992510: Wallstent Tracheobronchial Endoprosthesis and Unistep Plus Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Nov 18, 1999 after 114 days
- Product code: JCT (Prosthesis, Tracheal, Expandable)
- Device class: 2
- Regulation: 21 CFR 878.3720
- 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: 4 generations back to K923119 (1992). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964121: Wallstent Tracheobronchial Endoprosthesis, Boston Scientific Scimed, Inc. (1996) Summary page 4.

## Most influential descendants
- K152842: Wallstent RP Endoprosthesis Tracheobronchial, Wallstent  Endoprosthesis Tracheobronchial (2016), 0 descendants of its own

## Recalls of this device
- Jul 9, 2004 · Not classified · Z-1340-04: Specific lots of the WALLSTENT Endoprosthesis with UNISTEP Plus Delivery System were packaged without one of the three required directions for use.

## Indications for use
The WALLSTENT® Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

Source page: https://510kreport.com/device/K992510
Methodology: https://510kreport.com/methodology