ClearanceBrief
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)
Get daily alerts for FGESample briefCSV

Top companies in FGE

DateFirm and productCodeLinked 510(k)
Jun 1, 2017Boston Scientific Corporation
Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above UPN: M00547300
Terminated
FGENone listed
Jul 1, 2015Boston 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
FGEK102082
Mar 31, 2015Boston Scientific Corporation
Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits
Terminated
FGEK141335
Mar 27, 2015Boston 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
FGEK141335
Jan 10, 2014Boston Scientific Corporation
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: M00547110
Terminated
FGEK102082
Jan 10, 2014Boston 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
FGEK102082
Jun 18, 2013IDEV 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
FGEK111766
Jun 6, 2013Cordis 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
FGEK112522
Jun 6, 2013Cordis 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
FGEK081996
Feb 20, 2013Merit 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
FGEK121832
Sep 25, 2012Applied 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
FGEK910006
May 10, 2012Cordis 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
FGEK031777
K042969 +1
May 10, 2012Cordis 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
FGEK031777
K042969 +1
Mar 15, 2012Idev 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
FGEK093893
Feb 15, 2012Cordis 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
FGEK031777
Jan 11, 2012Navilyst 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
FGEK093392
Jan 11, 2012Navilyst 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
FGEK093392
Jan 19, 2011Cook 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
FGEK101095
Jan 19, 2011Cook 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
FGEK101095
Dec 16, 2010Ev3, 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
FGEK050725
Oct 7, 2010Navilyst 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
FGEK093392
Aug 25, 2010Boston 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
FGEK965147
Aug 25, 2010Boston 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
FGEK965147
Aug 25, 2010Boston 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
FGEK965147
Aug 25, 2010Boston 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
FGEK965147
Aug 25, 2010Boston 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
FGEK965147
Aug 25, 2010Boston 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
FGEK965147
Aug 25, 2010Boston 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
FGEK965147
Aug 25, 2010Boston 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
FGEK965147
Aug 25, 2010Boston 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
FGEK965147
Aug 25, 2010Boston 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
FGEK965147
Aug 25, 2010Boston 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
FGEK965147
Aug 25, 2010Boston 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
FGEK965147
Aug 25, 2010Boston 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
FGEK965147
Aug 25, 2010Boston 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
FGEK965147
Aug 25, 2010Boston 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
FGEK965147
Aug 25, 2010Boston 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
FGEK965147
Aug 25, 2010Boston 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
FGEK965147
Aug 25, 2010Boston 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
FGEK965147
Aug 25, 2010Boston 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
FGEK965147
Aug 25, 2010Boston 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
FGEK965147
Jun 14, 2010Medtronic 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
FGEK032768
May 13, 2010Ev3, 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
FGEK060057
Mar 25, 2010Boston 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
FGEK963397
Feb 22, 2010Merit 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
FGEK072720
Feb 22, 2010Merit 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
FGEK072720
Feb 22, 2010Merit 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
FGEK072720
Feb 22, 2010Merit 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
FGEK072720
Feb 22, 2010Merit 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
FGEK072720
Feb 22, 2010Merit 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
FGEK072720

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.