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) |
|---|---|---|---|
| Nov 25, 2019 | Boston Scientific Corporation Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm
UPN: M00536650 Terminated |
FGE | K133700 |
| Nov 25, 2019 | Boston Scientific Corporation Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640 Terminated |
FGE | K133700 |
| Nov 25, 2019 | Boston Scientific Corporation Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm
UPN: M00536630 Terminated |
FGE | K133700 |
| Nov 25, 2019 | Boston Scientific Corporation Boston Advanix Pancreatic Stent, Straight
Leading Barb, 10F x 4cm
UPN: M00536620 Terminated |
FGE | K133700 |
| Nov 25, 2019 | Boston Scientific Corporation Boston Scientific Advanix Pancreatic Stent, Straight
Leading Barb, 10F x 3cm
UPN: M00536610 Terminated |
FGE | K133700 |
| Dec 26, 2018 | Boston Scientific Corporation Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210 Terminated |
FGE | K965147 |
| Dec 26, 2018 | Boston Scientific Corporation Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220 Terminated |
FGE | K965147 |
| Dec 19, 2018 | Cook Inc. Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order Number G35570
The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of th Terminated |
FGE | K152524 |
| Dec 19, 2018 | Cook Inc. Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, Order Number G35569
The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of th Terminated |
FGE | K152524 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-125-14.0-80
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver Biliary 518 Stent 5mm x 60mm, Catalog Number: ZIB5-125-5.0-60
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K050698 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-80-5.0-80
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-80-5.0-60
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-80-5.0-40
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-80-5.0-30
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-80-5.0-20
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-80-4.0-80
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-80-14.0-80
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated 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. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated 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. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated 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. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated 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. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated 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. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated 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. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated 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. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated 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. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated 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. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated 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. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated 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. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated 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. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated 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. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated 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. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated 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. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated 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. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated 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. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated 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. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated 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. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated 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. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-80-5.0-80
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K050698 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-125-5.0-80
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K050698 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 5mm x 40mm, Catalog Number: ZIB5-125-5.0-40
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K050698 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 5mm x 30mm, Catalog Number: ZIB5-125-5.0-30
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K050698 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 5mm x 20mm, Catalog Number: ZIB5-125-5.0-20
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K050698 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 4mm x 80mm, Catalog Number: ZIB5-125-4.0-80
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K050698 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 4mm x 60mm, Catalog Number: ZIB5-125-4.0-60
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K050698 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 4mm x 40mm, Catalog Number: ZIB5-125-4.0-40
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K050698 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 4mm x 30mm, Catalog Number: ZIB5-125-4.0-30
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K050698 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 4mm x 20mm, Catalog Number: ZIB5-125-4.0-20
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K050698 |
| Nov 15, 2017 | Cordis Corporation Cordis S.M.A.R.T. Flex Biliary Stent System
Product Usage:
Is indicated for use in the palliation of malignant strictures in the biliary tree. Terminated |
FGE | K121125 |
| Jun 1, 2017 | Boston Scientific Corporation Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below
UPN: M00547340 Terminated |
FGE | None listed |
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