# K982184: Wallstent Endoprosthesis

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Scimed, Inc.
- Decided: Jul 21, 1998 after 29 days
- Product code: JCT (Prosthesis, Tracheal, Expandable)
- Device class: 2
- Regulation: 21 CFR 878.3720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K923119 (1992). 14 ancestors in all.
40 later devices descend from it; 3 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980163: Wallstent Tracheobronchial Endoprosthesis and Wallstent Tracheobronchial Endoprosthesis with Permalume Covering, Boston Scientific Scimed, Inc. (1998). Our OCR of the scanned summary read K880163, FDA’s number for Pregnancy (HCG) Card & Liquid Test (Ampcor, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “WALLSTENT® Tracheobronchial Endoprosthesis (12-30 mm)”.
- K980113: Wallstent Enteral Endoprosthesis, Boston Scientific Scimed, Inc. (1998) Summary page 9.
- K964121: Wallstent Tracheobronchial Endoprosthesis, Boston Scientific Scimed, Inc. (1996) Summary page 9.
- K964119: Wallstent Transhepatic Biliary Endoprosthesis, Boston Scientific Scimed, Inc. (1997) Summary page 9.
- K961262: Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary Endoprosthesis, Boston Scientific Scimed, Inc. (1996) Summary page 9.
- K954290: Wallstent Enteral Endoprothesis, Boston Scientific Scimed, Inc. (1996) Summary page 9.
- K940396: Wallstent Esophageal Prosthesis (Double), Boston Scientific Scimed, Inc. (1994) Summary page 9.
- K934116: Wallstent Tracheobronchial Prosthesis Modification, Boston Scientific Scimed, Inc. (1994) Summary page 9.

## Most influential descendants
- K012752: Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive (2001), 37 descendants of its own
- K073667: Niti-S Biliary Stent (2008), 23 descendants of its own
- K030107: 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MM (2003), 11 descendants of its own
- K113551: Esophageal TTS Stent (2012), 10 descendants of its own
- K061231: Wellflex  Biliary RX Stent System (2006), 10 descendants of its own

## Indications for use
The WALLSTENT® Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms. The WALLSTENT® Enteral Endoprosthesis is indicated for palliation of duodenal strictures caused by malignant neoplasms. The WALLSTENT® Endoprosthesis is indicated for use in the treatment of biliary strictures produced by malignant neoplasms. The WALLSTENT® Enteral Endoprosthesis is indicated for palliative treatment of colonic strictures caused by malignant neoplasms. The WALLSTENT® Esophageal Prosthesis is indicated for palliative treatment of esophageal strictures produced by malignant neoplasms.

Source page: https://510kreport.com/device/K982184
Methodology: https://510kreport.com/methodology