Stents, Drains And Dilators For The Biliary Ducts

FDA product code FGE · 462 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.5010
Review panel: GU
Implant: Yes
Life sustaining: Yes
Third party review: No
GMP exempt: No
Clearance span: 1982-08-10 – 2026-09-18

FGE 1990-10-26

ZIMMON ENDOSCOPIC PANCREATIC STENT

Applicant Wilson-Cook Medical, Inc.

K number K900923

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FGE 1990-10-22

SOEHENDRA STENT RETRIEVER

Applicant Wilson-Cook Medical, Inc.

K number K903420

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FGE 1990-10-10

COOK-GIANTURCO ROSCH BILIARY Z-STENT, MODIFICATION

Applicant Cook, Inc.

K number K903858

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FGE 1990-08-22

PR CANNULAS

Applicant Olympus Corp.

K number K902734

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FGE 1990-07-16

WILSON-COOK SYRINGE HOLDERS

Applicant Wilson-Cook Medical, Inc.

K number K902107

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FGE 1990-06-22

DOBBHOFF BILIARY STENT SET

Applicant Biosearch Medical Products, Inc.

K number K901582

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FGE 1990-06-22

BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON

Applicant Telemed Systems, Inc.

K number K901427

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FGE 1990-06-21

SURE-FLEX ANASTOMOTIC BALLOON DILATOR

Applicant Telemed Systems, Inc.

K number K901433

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FGE 1990-06-21

BILIARY BALLOON DILATOR

Applicant Telemed Systems, Inc.

K number K901432

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FGE 1990-06-18

TELEMED ERCP CANNULA

Applicant Telemed Systems, Inc.

K number K901431

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FGE 1990-05-11

CANDELA DIRECTABLE BILIARY CATHETER SYSTEM

Applicant Candela Laser Corp.

K number K900904

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FGE 1990-04-09

WILSON-COOK ENDOSCOPIC NASAL BILIARY DRAINAGE SETS

Applicant Wilson-Cook Medical, Inc.

K number K896323

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FGE 1990-03-29

BARD/ANGIOMED STENTS

Applicant C.R. Bard, Inc.

K number K896391

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FGE 1990-02-02

DOBBHOFF(R) ERCP CANNULA

Applicant Biosearch Medical Products, Inc.

K number K896518

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FGE 1990-01-30

PORGES ERCP CATHETERS

Applicant Porges Corp.

K number K896503

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FGE 1990-01-26

PORGES ENDOSCOPIC DORMIA EXTRACTORS, DORMIATRIPTOR

Applicant Porges Corp.

K number K896506

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FGE 1990-01-26

PORGES 2-WAY BALLOON EXTRACTION CATHETER

Applicant Porges Corp.

K number K896504

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FGE 1990-01-22

PORGES BILIARY STENTS

Applicant Porges Corp.

K number K896423

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FGE 1990-01-22

PORGES NASOBILIARY DRAIN

Applicant Porges Corp.

K number K896376

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FGE 1989-12-21

WILTEK BILIARY STENT SET

Applicant Wiltek Medical, Inc.

K number K894871

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FGE 1989-12-21

WILTEK E.R.C.P. CATHETER

Applicant Wiltek Medical, Inc.

K number K894867

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FGE 1989-12-08

WILSON-COOK GIANTURCO-ROSCH BILIARY Z STENT

Applicant Wilson-Cook Medical, Inc.

K number K896069

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FGE 1989-12-01

SCHNEIDER STENT WALLSTENT ENDOSCOPIC BILIARY ENDO.

Applicant Schneider Stent

K number K896163

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FGE 1989-09-29

BILIARY DIALATOR

Applicant Primrose Medical, Inc.

K number K884714

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FGE 1989-05-04

BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER

Applicant Porges Corp.

K number K892384

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FGE 1989-05-04

BILIARY ENDOPROSTHESIS FOR INTERNAL DRAINAGE SET

Applicant Porges Corp.

K number K892383

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FGE 1989-05-01

BURNEY GALLBLADDER CATHETER KIT

Applicant Mallinckrodt Critical Care

K number K880343

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FGE 1989-04-21

COOK-GIANTURCO BILIARY Z STENT

Applicant Cook, Inc.

K number K882610

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FGE 1989-02-16

EXPANDABLE BILIARY STENT ENDOPROSTHESIS

Applicant Schneider Intl., Ltd.

K number K885180

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FGE 1988-06-17

MODIFIED COPE SUTURE ANCHOR

Applicant Cook, Inc.

K number K873606

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FGE 1988-01-29

NAMIC HAWKINS UNIVERSAL DRAINAGE SET

Applicant North American Instrument Corp.

K number K873954

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FGE 1987-09-22

LINDEN STONE EXTRACTION BALLOON

Applicant Hobbs Medical, Inc.

K number K872509

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FGE 1987-09-21

AN3200 DOUBILET DRAIN

Applicant H.W. Andersen Products, Inc.

K number K872458

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FGE 1987-05-15

GASTROTOPO

Applicant Houston Biomedical, Inc.

K number K861291

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FGE 1986-11-04

BILIARY BALLOON CATHETER

Applicant Uresil Corp.

K number K863571

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FGE 1986-11-04

SHEATH, ENDOSCOPE

Applicant Endovations

K number K862059

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FGE 1986-10-29

BARD BALLOON DILATATION SYSTEM

Applicant C.R. Bard, Inc.

K number K863437

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FGE 1986-10-24

TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR GU

Applicant Cathaid, Inc.

K number K863957

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FGE 1986-05-19

LUNDERQUIST - RING PTC DRAINAGE CATHETER

Applicant Meadox Surgimed, Inc.

K number K861220

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FGE 1986-05-13

ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY

Applicant Endovations

K number K860990

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FGE 1986-03-11

ANGIOMED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGTAPHY

Applicant Angiomed U.S., Inc.

K number K855142

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FGE 1985-12-17

ZIMMON BILIARY STENT SET

Applicant Wilson-Cook Medical, Inc.

K number K851962

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FGE 1985-12-17

PVL-4.8-200 BALLOON STONE EXTRACTOR

Applicant Wilson-Cook Medical, Inc.

K number K851954

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FGE 1985-11-05

ENDODYNAMICS SIEGEL THERAPUTIC STENT

Applicant E-Z-Em, Inc.

K number K853666

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FGE 1985-10-04

BARD-PARKER BILIARY BALLOON CATHETER

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K852293

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FGE 1985-09-20

DAVOL RETRIEVAL BALLOON CATHETER

Applicant C.R. Bard, Inc.

K number K853543

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FGE 1985-09-11

GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO

Applicant Cook, Inc.

K number K851242

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FGE 1985-07-29

SOEHENDRA BILIARY DILATING CATHETER-SBDC-7

Applicant Wilson-Cook Medical, Inc.

K number K851960

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FGE 1985-07-03

OLBERT CATHETER SYSTEM FOR BILIARY TRACT DILATATIO

Applicant Meadox Surgimed, Inc.

K number K851647

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FGE 1985-06-13

VPDS-1 VENNES PANCREATIC DILATION SET

Applicant Wilson-Cook Medical, Inc.

K number K851956

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FGE 1985-02-14

BILIARY STENT PROSTHESIS

Applicant Mentor Corp.

K number K844384

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FGE 1984-10-02

CATH-TECH CHOLANGIOGRAPHY CATHETER

Applicant Catheter Technology Corp.

K number K842147

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FGE 1984-05-22

DILATION BALLOON CATHETER

Applicant Hobbs Medical, Inc.

K number K834413

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FGE 1984-04-20

DRAINAGE STENT

Applicant Microvasive

K number K834468

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FGE 1984-04-05

USCI ENDOPROSTHESIS

Applicant C.R. Bard, Inc.

K number K834574

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FGE 1984-03-22

BILIARY INDWELLING STENT

Applicant Hobbs Medical, Inc.

K number K834351

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FGE 1984-01-03

UMI PERCUTANEOUS TRANSHEPATIC CHOLAN

Applicant Universal Medical Instrument Corp.

K number K833937

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FGE 1983-12-27

KELLY CHOLANGIOCATH

Applicant Perry, Div.

K number K833920

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FGE 1983-03-09

COONS SOFT STENT

Applicant Medi-Tech, Inc.

K number K830483

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FGE 1983-01-18

KELLY INFLATABLE T DRAIN

Applicant Akron Catheter, Inc.

K number K823428

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FGE 1982-08-20

PIGTAIL STENTS

Applicant American Endoscopy, Inc.

K number K821819

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FGE 1982-08-10

PIGTAIL NASAL CATHETERS

Applicant American Endoscopy, Inc.

K number K821817

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