Panels › Gastroenterology, Urology › Product code FGE · Class 2
Stents, Drains And Dilators For The Biliary Ducts
Regulation 876.5010
10510(k)s in 12 months (478 all time)
12recalls in 12 months (452 all time)
439recalls that name a 510(k)
Top companies in FGE
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific | 56 | 81 |
| Ev3 Corporation | 12 | 71 |
| Bard Peripheral Vascular, Inc. | 2 | 69 |
| Edwards Lifesciences, LLC | 7 | 52 |
| Cordis Corp. | 38 | 14 |
| Cook Medical Incorporated | 0 | 39 |
| Cook Incorporated | 22 | 13 |
| Wilson-Cook Medical, Inc. | 20 | 15 |
| Hobbs Medical, Inc. | 3 | 21 |
| Guidant Corp. | 20 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2004 | Ev3 Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SERB65-10-30-120 (.035) (Biliary) Terminated |
FGE | K033314 |
| Aug 7, 2004 | Ev3 Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SER6-10-30-135 (.018) (Biliary) Terminated |
FGE | K033314 |
| Jul 20, 2004 | Boston Scientific Corp Boston Scientific/Microvasive brand Biliary Stent Kit, 7 FR x 10 cm, sterile, single use only; Ref 3102. Terminated |
FGE | K834468 |
| Jul 20, 2004 | Boston Scientific Corp Boston Scientific/Microvasive brand Biliary Stent Kit, 7 FR x 5 cm, sterile, single use only; Ref 3101. Terminated |
FGE | K834468 |
| Jul 20, 2004 | Wilson-Cook Medical Inc Biliary Stent Introducer Set Terminated |
FGE | K851962 |
| Jul 20, 2004 | Cordis Corporation This medical device is packaged in an inner Tyvek pouch and then in an outer carton. The outer carton is labeled as Cordis PRECISE RX Nitinol Stent Transhepatic Biliary System Cordis a Johnson n Joh Terminated |
FGE | K032137 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery system 5mm x 14mm 80 cm .014" REF PMP4-5-14-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 5mm x 18mm 80 cm .014" REF PMP 4-5-18-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 5mm x 21mm 80 cm .014" REF PMP 4-5-21-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 6mm x 14mm 80 cm .014" REF PMP 4-6-14-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 6mm x 18mm 80 cm 0.14" REF PMP 4-6-18-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 6mm x 21mm 80 cm .014" REF PMP 4-6-21-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 7mm x 14mm 80 cm .014" REF PMP 4-7-14-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 7mm x 18mm 80 cm .014" REF PMP 4-7-18-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 7mm x 21mm 80 cm .014" REF PMP4-7-21-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 5mm x 14mm 80 cm .018" REF PMP 8-5-14-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 5mm x 18mm 80 cm .018" REF PMP 8-5-18-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 5mm x 21mm 80 cm 0.18" REF PMP 8-5-21-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 6mm x 14 80 cm .018" REF PMP 8-6-14-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 6mm x 18mm 80 cm .018" REF PMP8-6-18-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 6mm x 21mm 80 cm .018" REF PMP 8-6-21-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 7mm x 14mm 80 cm .018" REF PMP 8-7-14-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 7mm x 18mm 80 cm .018" REF PMP 8-7-18-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 7mm x 21mm 80 cm .018" REF PMP 8-7-21-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 5mm x 14 mm 80 cm .014" REF PMB 4-5-14-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 5mm x 18mm 80 cm .014" REF PMB 4-5-18-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 5mm x 21mm 80 cm .014" REF PMB 4-5-21-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 6mm x 14mm 80 cm .014" REF PMB 4-6-14-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 6mm x 18 mm 80 cm .014" REF PMB 4-6-18-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 6mm x 21mm 80 cm .014" REF PMB 4-6-21-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 7mm x 14mm 80 cm .014" REF PMB 4-7-14-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 7mm x 18mm 80 cm .014" REF PMB 4-7-18-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 7mm x 21mm 80 cm .014" REF PMB 4-7-21-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 5mm x 14mm 80 cm .018" REF PMB 8-5-14-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 5mm x 18mm 80 cm .018" REF PMB 8-5-18-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 5mm x 21mm 80 cm .018'" REF PMB 8-5-21-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 6mm x 14mm 80 cm .018" REF PMB 8-6-14-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 6mm x 18mm 80 cm .018" REF PMB 8-6-18-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 6mm x 21mm 80 cm .018" REF PMB 8-6-21-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 7mm x 14mm 80 cm .018" REF PMB 8-7-14-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 7mm x 18mm 80 cm .018" REF PMB 8-7-18-80 Terminated |
FGE | K033134 |
| Jul 20, 2004 | Boston Scientific Corporation Wallstent Rx Biliary Endoprosthesis with Unistep Plus Delivery System 8 Fr, 10mm x 60mm
Catalog Number: 6965 Terminated |
FGE | K012752 K030107 |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 7mm x 21mm 80 cm .018'" REF PMB 8-7-21-80 Terminated |
FGE | K033134 |
| Jan 14, 2004 | Wilson-Cook Medical Inc Oasis-One Action Stent Introduction System with ST-2 Soehendra Tannenbaum Biliary Stent, (11.5 French size only), Guiding Catheter: 6 FR, Minimum Accessory Channel Size: 3.7mm, Wire Guide Sold Separat Terminated |
FGE | K851962 |
| Nov 6, 2003 | Wilson-Cook Medical Inc ZILBS-8-6, ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM, Stent Diameter: 8 MM. Stent Length: 6 CM., Accepts .035'' Wire Guide, Introduction system: 7 FR., Minimum Scope Channel: 2.8 MM., Disposable-Si Terminated |
FGE | K020788 |
| Oct 31, 2003 | Wilson-Cook Medical Inc APSOF-7-4-RB, ZIMMON PANCREATIC STENT W/RADIOPAQUE BANDS, Stent Diameter: 7 FR., Length (Between Curl and Flap): 4 CM, For Use With Wilson-Cook Stent Introduction System: 7 FR. Minimum Accessory Chann Terminated |
FGE | None listed |
| Aug 26, 2003 | Wilson-Cook Medical Inc Zilver Expandable Metal Biliary Stent Terminated |
FGE | K020788 |
| Aug 26, 2003 | Wilson-Cook Medical Inc Za-Stent Expandable Metal Biliary Stent Terminated |
FGE | K941350 |
| Aug 26, 2003 | Wilson-Cook Medical Inc Spiral Z Expandable Metal Biliary Stent Terminated |
FGE | K941350 |
| May 22, 2003 | ev3, Inc. Protg Self-Expanding Nitinol Stent 6 mm x 40 mm, Model Number SER6-6-40-135 Terminated |
FGE | K023243 |
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