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)
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Top companies in FGE

DateFirm and productCodeLinked 510(k)
Oct 14, 2026W L Gore & Associates, Inc.
Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-ex
Open, Classified
FGEK170740
Oct 9, 2026Boston Scientific Corporation
NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Open, Classified
FGEK223592
Sep 18, 2026Olympus Corporation of the Americas
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
Open, Classified
FGENone listed
Aug 7, 2026W L Gore & Associates, Inc.
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.
Open, Classified
FGEK170740
Aug 7, 2026W L Gore & Associates, Inc.
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.
Open, Classified
FGEK170740
Jul 1, 2026Boston Scientific Corporation
CRE Pro Wireguided 18-20mm 240cm
Open, Classified
FGEK112994
Jul 1, 2026Boston Scientific Corporation
CRE Pro Wireguided 15-18mm 240cm
Open, Classified
FGEK112994
Jul 1, 2026Boston Scientific Corporation
CRE Pro Wireguided 12-15mm 240cm
Open, Classified
FGEK112994
Jul 1, 2026Boston Scientific Corporation
CRE Pro Wireguided 10-12mm 240cm
Open, Classified
FGEK112994
Jul 1, 2026Boston Scientific Corporation
CRE Pro Wireguided 8-10mm 240cm
Open, Classified
FGEK112994
Jul 1, 2026Boston Scientific Corporation
CRE Pro Wireguided 6-8mm 240cm
Open, Classified
FGEK112994
Apr 6, 2026Cook Incorporated
COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
Open, Classified
FGEK173035
Sep 23, 2025Boston Scientific Corporation
Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
Open, Classified
FGEK102082
Oct 25, 2024Olympus Corporation of the Americas
EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endosco
Open, Classified
FGEK180086
Jun 27, 2024Cook Incorporated
Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and
Open, Classified
FGEK173035
Jun 27, 2024Cook Incorporated
Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and absce
Open, Classified
FGEK173035
Apr 12, 2024Cook Incorporated
Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary an
Open, Classified
FGEK183036
Apr 12, 2024Cook Incorporated
Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the
Open, Classified
FGEK183036
Apr 12, 2024Cook Incorporated
Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary a
Open, Classified
FGEK183036
Apr 12, 2024Cook Incorporated
Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters. REFERE
Open, Classified
FGEK152524
Feb 22, 2024W.L. Gore & Associates, Inc.
GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number VSWVN1008, 10 mm x 8 cm; no holes
Open, Classified
FGEK170740
Jan 31, 2024Olympus Corporation of the Americas
EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-2055
Open, Classified
FGEK180086
Jan 31, 2024Olympus Corporation of the Americas
EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1855
Open, Classified
FGEK180086
Jan 31, 2024Olympus Corporation of the Americas
EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1555
Open, Classified
FGEK180086
Jan 31, 2024Olympus Corporation of the Americas
EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1355
Open, Classified
FGEK180086
Jan 31, 2024Olympus Corporation of the Americas
EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-1055
Open, Classified
FGEK180086
Jan 31, 2024Olympus Corporation of the Americas
EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-0855
Open, Classified
FGEK180086
Jan 31, 2024Olympus Corporation of the Americas
EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-2080
Open, Classified
FGEK180086
Jan 31, 2024Olympus Corporation of the Americas
EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1880
Open, Classified
FGEK180086
Jan 31, 2024Olympus Corporation of the Americas
EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1580
Open, Classified
FGEK180086
Jan 31, 2024Olympus Corporation of the Americas
EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1380
Open, Classified
FGEK180086
Jan 31, 2024Olympus Corporation of the Americas
EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1080
Open, Classified
FGEK180086
Jan 31, 2024Olympus Corporation of the Americas
EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-0880
Open, Classified
FGEK180086
Dec 1, 2023Wilson-Cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree
Open, Classified
FGEK171223
Dec 1, 2023Wilson-Cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree
Open, Classified
FGEK171223
Dec 1, 2023Wilson-Cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate strictures of the biliary tree
Open, Classified
FGEK171223
Dec 1, 2023Wilson-Cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree
Open, Classified
FGEK171223
Dec 1, 2023Wilson-Cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree
Open, Classified
FGEK171223
Dec 1, 2023Wilson-Cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree
Open, Classified
FGEK171223
Dec 1, 2023Wilson-Cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree
Open, Classified
FGEK171223
Oct 7, 2022Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent (contained in kit 6501) Catalog Number: 6541
Open, Classified
FGEK834351
Oct 7, 2022Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent Catalog Number: 6584
Open, Classified
FGEK834351
Oct 7, 2022Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent Catalog Number: 6582
Open, Classified
FGEK834351
Oct 7, 2022Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent Catalog Number: 6568
Open, Classified
FGEK834351
Oct 7, 2022Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent Catalog Number: 6567
Open, Classified
FGEK834351
Oct 7, 2022Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent Catalog Number: 6566
Open, Classified
FGEK834351
Oct 7, 2022Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent Catalog Number: 6562
Open, Classified
FGEK834351
Oct 7, 2022Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent Catalog Number: 6548
Open, Classified
FGEK834351
Oct 7, 2022Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent Catalog Number: 6544
Open, Classified
FGEK834351
Oct 7, 2022Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent Catalog Number: 6535
Open, Classified
FGEK834351

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