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) |
|---|---|---|---|
| Jun 1, 2017 | Boston Scientific Corporation Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above
UPN: M00547300 Terminated |
FGE | None listed |
| Jul 1, 2015 | Boston Scientific Corporation Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000
The Extractor Pro RX Retrieval Balloon Catheters are intended for use end Terminated |
FGE | K102082 |
| Mar 31, 2015 | Boston Scientific Corporation Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits Terminated |
FGE | K141335 |
| Mar 27, 2015 | Boston Scientific Corporation Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage Catheter APD Drainage Catheter, Expel" Large Capacity Drainag Terminated |
FGE | K141335 |
| Jan 10, 2014 | Boston Scientific Corporation Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above
UPN: M00547110 Terminated |
FGE | K102082 |
| Jan 10, 2014 | Boston Scientific Corporation Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above
UPN: M00547100
The Extractor Pro XL Retrieval Balloon Catheter is used endoscopically to 1) remove stones from the b Terminated |
FGE | K102082 |
| Jun 18, 2013 | IDEV Technologies, Inc. IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms Terminated |
FGE | K111766 |
| Jun 6, 2013 | Cordis Corporation FLEXSTENT Biliary Self-Expanding Stent System.
Product Usage:
The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree. Terminated |
FGE | K112522 |
| Jun 6, 2013 | Cordis Corporation FLEXSTENT Biliary Self-Expanding Stent System.
Product Usage:
The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree. Terminated |
FGE | K081996 |
| Feb 20, 2013 | Merit Medical Systems, Inc. Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system. Terminated |
FGE | K121832 |
| Sep 25, 2012 | Applied Medical Resources Corp Biliary Catheters (Models A47XX and CB0XXXXX):
Model Numbers & Description:
A4752, SYNTEL BILIARY 5F-23CM CATHETER;
A4754, SYNTEL BILIARY 5F-40CM CATHETER;
A4762, SYNTEL BILIARY 6F-23CM CATHETER;
CB0 Terminated |
FGE | K910006 |
| May 10, 2012 | Cordis Corporation Product is labeled in part: Inner Label "***SMART Control Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. CONTROL Nitinol Stent Transhepatic Biliary System***Assemble Terminated |
FGE | K031777 K042969 +1 |
| May 10, 2012 | Cordis Corporation Product is labeled in part: Inner Label "***S.M.A.R.T. Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System***Assembled in Mexico Terminated |
FGE | K031777 K042969 +1 |
| Mar 15, 2012 | Idev Technologies, Inc. SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System.
Intended to be used for palliative treatment of biliary strictures produced by malignant neoplasms. Terminated |
FGE | K093893 |
| Feb 15, 2012 | Cordis Corporation S.M.A.R.T. CONTROL Transhepatic Biliary Stent. The Self-Expanding Nitinol Biliary Stent is delivered by catheter for the palliation of malignant neoplasms in the biliary tree.
Model numbers are Cxx Terminated |
FGE | K031777 |
| Jan 11, 2012 | Navilyst Medical, Inc Exodus(TM) 10 F (3.4 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/Catalog No. 10013, UPN/Product No. H965100131, STERILE --- Package/Box Units: Box of 5 eaches --- Terminated |
FGE | K093392 |
| Jan 11, 2012 | Navilyst Medical, Inc Exodus(TM) 8F (2.7 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/ Catalog No. 10005, UPN/Product No. H965100051, STERILE --- Package/Box Units: Box of 5 eaches --- M Terminated |
FGE | K093392 |
| Jan 19, 2011 | Cook Endoscopy DPOC-20, Direct Peroral Cholangioscopy Balloon, G54951, 20 mm/17 mL, Rx Only, Cook Medical, Winston-Salem, NC 27105
This device is intended to guide both optical and accessory devices for diagnostic Terminated |
FGE | K101095 |
| Jan 19, 2011 | Cook Endoscopy DPOC-15, Cholangioscopy Access Balloon, G54951, 15 mm, Rx only, Cook Medical, Winston-Salem, NC 27105
This device is intended to guide both optical and accessory devices for diagnostic and therapeuti Terminated |
FGE | K101095 |
| Dec 16, 2010 | Ev3, Inc. ev3 Inc. 4600 Nathan Lane, Plymouth, MN Protg " GPS" Self-Expanding Biliary Stent System, Sterile EO, 14 mm 60mm 80 cm, REF SERB65-14-60-80, Rx only.
ev3 Inc. 4600 Nathan Lane, Plymouth, MN Protg " Terminated |
FGE | K050725 |
| Oct 7, 2010 | Navilyst Medical, Inc Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centenn Terminated |
FGE | K093392 |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 11.5Fr-15cm, M00539390, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for draina Terminated |
FGE | K965147 |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 11.5Fr-12cm, M00539380, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for draina Terminated |
FGE | K965147 |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 11.5Fr-10cm, M00539370, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for draina Terminated |
FGE | K965147 |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 11.5Fr-7cm, M00539360, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainag Terminated |
FGE | K965147 |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 11.5Fr-5cm, M00539350, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainag Terminated |
FGE | K965147 |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 10Fr-15cm, M00539340, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage Terminated |
FGE | K965147 |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 10Fr-12cm, M00539330, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage Terminated |
FGE | K965147 |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 10Fr-10cm, M00539320, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage Terminated |
FGE | K965147 |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 10Fr-7cm, M00539310, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage Terminated |
FGE | K965147 |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 10Fr-5cm, M00539300, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage Terminated |
FGE | K965147 |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 8.5Fr-15cm, M00539290, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainag Terminated |
FGE | K965147 |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 8.5Fr-12cm, M00539280, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainag Terminated |
FGE | K965147 |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 8.5Fr-10cm, M00539270, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainag Terminated |
FGE | K965147 |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 8.5Fr-7cm, M00539260, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage Terminated |
FGE | K965147 |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 8.5Fr-5cm, M00539250, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage Terminated |
FGE | K965147 |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 7Fr-15cm, M00539240, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage Terminated |
FGE | K965147 |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 7Fr-12cm, M00539230, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage Terminated |
FGE | K965147 |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 7Fr-10cm, M00539220, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage Terminated |
FGE | K965147 |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 7Fr-7cm, M00539210, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage o Terminated |
FGE | K965147 |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 7Fr-5cm, M00539200, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage o Terminated |
FGE | K965147 |
| Jun 14, 2010 | Medtronic CardioVascular Medtronic Racer Biliary Stent System, Model number XD518YF, UPC code 00721902758164 in a box containing sterilized pouch with product, manufactured by Medtronic Vascular, Sunnyvale, CA.
Medical devic Terminated |
FGE | K032768 |
| May 13, 2010 | Ev3, Inc. ev3 Protg EverFlex Self-Expanding Biliary Stent System, Sterile EO, (REF: PRB35-06-150-080, REF PRB35-06-120-120 and PRB35-06-150-120), 4.5 - 5.5mm, Expiration: 2011-10-01, Rx only. ev3 Inc., 4500 Terminated |
FGE | K060057 |
| Mar 25, 2010 | Boston Scientific Corporation Boston Scientific, Ultra-thin" Diamond" Balloon Dilatation Catheters, M001164040 (DT/3-4/5/40, 16-404), M001164360 (DT/5-2/5/40, 16-436),M001164620 (DT/6-4/5/40, 16-462), Made in Ireland, Ballybrit Terminated |
FGE | K963397 |
| Feb 22, 2010 | Merit Medical Systems, Inc. Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-210, 10 x 80, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Intended for palliation of malignant neop Terminated |
FGE | K072720 |
| Feb 22, 2010 | Merit Medical Systems, Inc. Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-209, 10 x 60, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Intended for palliation of malignant neop Terminated |
FGE | K072720 |
| Feb 22, 2010 | Merit Medical Systems, Inc. Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-208, 10 x 40, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Intended for palliation of malignant neop Terminated |
FGE | K072720 |
| Feb 22, 2010 | Merit Medical Systems, Inc. Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-206, 8 x 80, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Intended for palliation of malignant neopl Terminated |
FGE | K072720 |
| Feb 22, 2010 | Merit Medical Systems, Inc. Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-205, 8 x 60, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Intended for palliation of malignant neopl Terminated |
FGE | K072720 |
| Feb 22, 2010 | Merit Medical Systems, Inc. Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-204, 8 x 40, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Intended for palliation of malignant neopl Terminated |
FGE | K072720 |
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