LIFESTENT LP SDS BILIARY ENDOPROSTHESIS— 510(k) K041370

Clearance details

Applicant

Orbus Medical Technologies

Product code

Code FGE

Device class

Class 2

Regulation

21 CFR 876.5010

Advisory panel

Gastroenterology, Urology

Date received

2004-05-24

Decision date

2004-06-24

Decision

Unknown

Clearance type

Special

Location

Fort Lauderdale, FL, US

• K254179 — Drainage Catheter2026-09-18
• K262913 — Protégé EverFlex Self-expanding Peripheral Stent System2026-09-17
• K260835 — ARCHIMEDES Biodegradable Stent (Medium)2026-07-27
• K253393 — Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-1280192026-06-24
• K253832 — Dilation Balloon Catheter2026-04-24

• K041032 — MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS2004-05-10
• K040550 — LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS2004-03-16
• K033212 — LIFESTENT SDS BILIARY ENDOPROSTHESIS2003-10-30
• K023308 — LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS2003-04-14
• K023121 — LIFESTENT BILIARY ENDOPROSTHESIS2003-03-10

Death

52

Injury

2,347

Malfunction

9,798

Other

1

Total

12,198

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →