MODIFICATION TO: ZILVER 635 BILIARY STENT— 510(k) K043481

Clearance details

Applicant

Cook, Inc.

Product code

Code FGE

Device class

Class 2

Regulation

21 CFR 876.5010

Advisory panel

Gastroenterology, Urology

Date received

2004-12-15

Decision date

2004-12-29

Decision

Unknown

Clearance type

Special

Location

Bloomington, IN, US

• 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
• K251658 — Endoflux Biliary & Pancreatic Stent Sets2026-04-16
• K253987 — BARE Wireguided Balloon Dilation Catheter (1235)2026-03-13

• K133130 — BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER2015-01-09
• K140593 — ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE2014-12-15
• K132592 — FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET2014-10-09
• K133597 — CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY2014-04-18
• K131772 — CANTATA(R) 2.9 MICROCATHETER2014-02-20

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 →

• Z-0324-2019 — Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-125-12.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.Class II·Terminated·Cook Medical Incorporated·20180925
• Z-0325-2019 — Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-125-12.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.Class II·Terminated·Cook Medical Incorporated·20180925
• Z-0326-2019 — Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-125-12.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.Class II·Terminated·Cook Medical Incorporated·20180925
• Z-0327-2019 — Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-125-12.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.Class II·Terminated·Cook Medical Incorporated·20180925
• Z-0328-2019 — Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-125-14.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.Class II·Terminated·Cook Medical Incorporated·20180925
• Z-0329-2019 — Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-125-14.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.Class II·Terminated·Cook Medical Incorporated·20180925
• Z-0330-2019 — Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-125-14.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.Class II·Terminated·Cook Medical Incorporated·20180925
• Z-0331-2019 — Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-125-4.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.Class II·Terminated·Cook Medical Incorporated·20180925
• Z-0332-2019 — Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-125-5.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.Class II·Terminated·Cook Medical Incorporated·20180925
• Z-0333-2019 — Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-125-5.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.Class II·Terminated·Cook Medical Incorporated·20180925
• Z-0334-2019 — Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-125-5.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.Class II·Terminated·Cook Medical Incorporated·20180925
• Z-0335-2019 — Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-125-5.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.Class II·Terminated·Cook Medical Incorporated·20180925
• Z-0336-2019 — Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-125-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.Class II·Terminated·Cook Medical Incorporated·20180925
• Z-0337-2019 — Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-80-12.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.Class II·Terminated·Cook Medical Incorporated·20180925
• Z-0338-2019 — Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-80-12.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.Class II·Terminated·Cook Medical Incorporated·20180925
• Z-0339-2019 — Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-80-12.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.Class II·Terminated·Cook Medical Incorporated·20180925
• Z-0340-2019 — Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-80-12.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.Class II·Terminated·Cook Medical Incorporated·20180925
• Z-0341-2019 — Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-80-14.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.Class II·Terminated·Cook Medical Incorporated·20180925
• Z-0342-2019 — Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-80-14.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.Class II·Terminated·Cook Medical Incorporated·20180925
• Z-0343-2019 — Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-80-14.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.Class II·Terminated·Cook Medical Incorporated·20180925

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K043481.