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) |
|---|---|---|---|
| Jan 19, 2010 | Medtronic CardioVascular Complete SE Biliary Stent System, SC680L (6 mm x 120 mm), lot number 0000983806, UPC code 006133994186669, use by date 03/17/2011, manufactured by Medtronic CardioVascular, Santa Rosa, CA.
Indicate Terminated |
FGE | K062264 |
| Jan 19, 2010 | Medtronic CardioVascular Complete SE Biliary Stent System, SC5120L (5 mm x 12 mm), lot number 0000983799, UPC code 00613994186478, use by date 03/17/2011, manufactured by Medtronic CardioVascular, Santa Rosa, CA.
Indicated Terminated |
FGE | K062264 |
| Dec 1, 2009 | Ev3, Inc. Protg EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6 x 150mm, Model # PRB35-06-150-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, MN 55442-2920, Rx onl Terminated |
FGE | K060057 |
| Sep 8, 2009 | Ev3, Inc. ev3 The Endovascular Company, Protege GPS 8mm x 40mm Self Expanding Peripheral Stent System , Rx Only, and SERP65-08-40-120.
In the US, the intended as a palliative treatment of malignant neoplasms i Terminated |
FGE | K033314 |
| Sep 8, 2009 | Ev3, Inc. ev3 The Endovascular Company, Protege GPS 6mm x 80mm Self Expanding Peripheral Stent System , Rx Only, and SERP65-06-80-120.
In the US, the intended as a palliative treatment of malignant neoplasms Terminated |
FGE | K033314 |
| Sep 8, 2009 | Ev3, Inc. ev3 The Endovascular Company, Protege GPS 6mm x 80mm Self Expanding Biliary Stent System, Rx Only, and SERB65-06-80-120.
In the US, the intended as a palliative treatment of malignant neoplasms in th Terminated |
FGE | K033314 |
| Sep 8, 2009 | Ev3, Inc. ev3 The Endovascular Company, Protege GPS 8mm x 40mm Self Expanding Biliary Stent System, Rx Only, and SERB65-08-40-120.
In the US, the intended as a palliative treatment of malignant neoplasms in th Terminated |
FGE | K033314 |
| Aug 27, 2009 | Boston Scientific Corporation Boston Scientific (1) Flexima Regular Biliary Catheter System with RO Marker, 8 FR (2.7 mm) with Glidex hydrogel Coating Locking Pigtail and Radiopaque Marker, REF /Catalog No. 27-260 UPN; M0012726 Terminated |
FGE | K023870 |
| Jun 17, 2009 | Bard Peripheral Vascular Inc Bard E LUMINEXX Biliary Stent, Size: 14mm x 80mm, Product Number: ZBM14080. Terminated |
FGE | K063532 |
| Jun 17, 2009 | Bard Peripheral Vascular Inc Bard E LUMINEXX Biliary Stent, Size 14mm x 60mm, Product Number: ZBM14060. Terminated |
FGE | K063532 |
| Jun 17, 2009 | Bard Peripheral Vascular Inc Bard E LUMINEXX Biliary Stent, Size: 14mm x 40mm, Product Number: ZBM14040. Terminated |
FGE | K063532 |
| Jun 17, 2009 | Bard Peripheral Vascular Inc Bard E LUMINEXX Biliary Stent, Size: 14mm x 30mm, Product Number: ZBM14030. Terminated |
FGE | K063532 |
| Jun 17, 2009 | Bard Peripheral Vascular Inc Bard E LUMINEXX Biliary Stent, Size: 12mm x 80mm Product Number: ZBM12080. Terminated |
FGE | K063532 |
| Jun 17, 2009 | Bard Peripheral Vascular Inc Bard E LUMINEXX Biliary Stent, Size: 12mm x 60mm, Product Number: ZBM12060. Terminated |
FGE | K063532 |
| Jun 17, 2009 | Bard Peripheral Vascular Inc Bard E LUMINEXX Biliary Stent, Size: 12mm x 40mm, Product Number: ZBM12040. Terminated |
FGE | K063532 |
| Jun 17, 2009 | Bard Peripheral Vascular Inc Bard E LUMINEXX Biliary Stent, Size: 6mm x 80mm, Product Number: ZBM06080. Terminated |
FGE | K063532 |
| Jun 17, 2009 | Bard Peripheral Vascular Inc Bard E LUMINEXX Biliary Stent, Size: 6mm x 60mm, Product Number: ZBM06060. Terminated |
FGE | K063532 |
| Jun 17, 2009 | Bard Peripheral Vascular Inc Bard E LUMINEXX Biliary Stent, Size: 6mm x 40mm, Product Number: ZBM06040. Terminated |
FGE | K063532 |
| Jun 17, 2009 | Bard Peripheral Vascular Inc Bard E LUMINEXX Biliary Stent, Size: 6mm x 30mm, Product Number: ZBM06030. Terminated |
FGE | K063532 |
| Jun 17, 2009 | Bard Peripheral Vascular Inc Bard E LUMINEXX Biliary Stent,Size: 6mm x 20mm, Product Number: ZBM06020. Terminated |
FGE | K063532 |
| Jun 17, 2009 | Bard Peripheral Vascular Inc Bard E LUMINEXX Biliary Stent, Size: 14mm x 60mm, Product Number: ZBL14060. Terminated |
FGE | K063532 |
| Jun 17, 2009 | Bard Peripheral Vascular Inc Bard E LUMINEXX Biliary Stent, Size: 12mm x 40mm, Product Number: ZBL12040. Terminated |
FGE | K063532 |
| Jun 17, 2009 | Bard Peripheral Vascular Inc Bard E LUMINEXX, Biliary Stent Size: 6mm x 80mm, Product Number: ZBL06080. Terminated |
FGE | K063532 |
| Jun 17, 2009 | Bard Peripheral Vascular Inc Bard E LUMINEXX Biliary Stent, Size: 6mm x 40mm, Product Number: ZBL06040. Terminated |
FGE | K063532 |
| Jun 17, 2009 | Bard Peripheral Vascular Inc Bard E LUMINEXX Biliary Stent, Size: 5mm x 120mm, Product Number: ZBL05120. Terminated |
FGE | K063532 |
| May 21, 2009 | Boston Scientific Corporation Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
UPN# DESCRIPTION
M0064101110 Percutaneous Nephrostomy Catheters Percutaneous
Terminated |
FGE | K820867 |
| May 21, 2009 | Boston Scientific Corporation Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
UPN # Description
M0064102040 Percuflex Locking Loop Nephrostomy Catheters
Terminated |
FGE | K820867 |
| May 21, 2009 | Boston Scientific Corporation Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
UPN# DESCRIPTION
M0064102020 Percuflex All Purpose Drainage Catheters
Terminated |
FGE | None listed |
| May 21, 2009 | Boston Scientific Corporation Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
UPN# DESCRIPTION
M001231360 IE TEMP TIP 8/ Terminated |
FGE | K900205 |
| May 21, 2009 | Boston Scientific Corporation Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
UPN# DESCRIPTION
M001213060 VSCTT/LOOP/12 Terminated |
FGE | K900205 |
| May 21, 2009 | Boston Scientific Corporation Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
UPN# DESCRIPTION
M001245260 VTCG/8/25
M001245270 VTCG/10/25
Terminated |
FGE | K811378 |
| May 21, 2009 | Boston Scientific Corporation Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
UPN# DESCRIPTION
M001272600 FLEXIMA BILIARY REG RO 8F/35CM
M0 Terminated |
FGE | K023870 |
| May 21, 2009 | Boston Scientific Corporation Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
UPN# DESCRIPTION
M001201050 VSKCL-12
M001201060 VSKCL-14
M00 Terminated |
FGE | K811378 |
| May 21, 2009 | Boston Scientific Corporation Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
UPN# DESCRIPTION
M001221000 AA/8/30
M001221010 AA/10/30
M001 Terminated |
FGE | K811378 |
| Mar 18, 2009 | Medtronic Cardiovascular Medtronic COMPLETE SE Self Expanding Biliary Stent System, Model number SC760L, includes a pre-loaded self-expanding Nickel-Titanium (Nitinol) stent with 8 tantalum radiopaque markers, 4 on each end, Terminated |
FGE | K062264 |
| Jan 13, 2009 | Merit Medical Systems, Inc. ReSolve Hydrophilic Coated Locking Biliary Catheter, REF RBC-14-038, 14F, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Used for drainage of bile within the biliary system. Terminated |
FGE | K063733 |
| Jan 13, 2009 | Merit Medical Systems, Inc. ReSolve Hydrophilic Coated Locking Biliary Catheter, 12F, REF RBC-12-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Used for drainage of bile within the biliary system. Terminated |
FGE | K063733 |
| Jan 13, 2009 | Merit Medical Systems, Inc. ReSolve Hydophilic Coated Locking Biliary Catheter, REF RBC-10-038, 10F, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095
Used for drainage of bile within the biliary system. Terminated |
FGE | K063733 |
| Jan 13, 2009 | Merit Medical Systems, Inc. ReSolve Hydrophilic Coated Locking Biliary Catheter, REF RBC-8-038, 8.5 F, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Used for drainage of bile within the biliary system. Terminated |
FGE | K063733 |
| Oct 14, 2008 | Cook Endoscopy Zilver Expandable Metal Biliary Stent System, ZILBS-10-6, Stent Diameter: 10mm, Stent Length: 6cm, Introduction System: 7 FR., Disposable-Single Use Only, Rx Only, Cook GI Endoscopy, Winston-Salem, N Terminated |
FGE | K020788 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070301CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100903CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100803CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100801CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100603CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100601CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100403CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100401CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100303CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100301CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
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