FDA Product Code
FDA Product Code FGE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5010
510(k) Clearances — 478 records · page 5 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K912122 | CHOLANGIOGRAPHY CATHETER | Wiltek Medical, Inc. | 1991-09-23 | Traditional | PDF ↗ |
| K912971 | INTHERM RADIALLY EXPANDING DILATER | Interventional Therapeutics Corp. | 1991-09-13 | Traditional | PDF ↗ |
| K900205 | DRAINAGE CATHETERS W/A DISSOLVABLE TIP | Boston Scientific Corp | 1991-08-20 | Traditional | PDF ↗ |
| K911581 | PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION | Johnson & Johnson Interventional Systems | 1991-06-04 | Traditional | PDF ↗ |
| K910671 | MODEL GS-4700 COMMON DUCT STONE REMOVING KIT | Solos Endoscopy, Inc. | 1991-05-10 | Traditional | PDF ↗ |
| K911292 | SCHNEIDER WALLSTENT(R) | Pfizer Hospital Products Group, Inc. | 1991-05-01 | Traditional | PDF ↗ |
| K910219 | LAPAROMED CHOLANGIOGRAM DEVICE | Laparomed Corp. | 1991-04-08 | Traditional | PDF ↗ |
| K910931 | BILIARY BALLOON DILATATION CATHETER | Boston Scientific Corp | 1991-04-02 | Traditional | PDF ↗ |
| K910493 | AVD INTIMAX CHOLANGIOGRAPHY CATHETER | Applied Vascular Devices, Inc. | 1991-03-28 | Traditional | PDF ↗ |
| K905738 | OPERATIVE CHOLANGIOGRAPHIC CATHETER | Applied Vascular Devices, Inc. | 1991-03-21 | Traditional | PDF ↗ |
| K910768 | SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE | Surgitek Medical Engineering Corp. | 1991-03-19 | Traditional | PDF ↗ |
| K904669 | BALLOON CATHETERS | Olympus Corp. | 1991-03-15 | Traditional | PDF ↗ |
| K910006 | AVD INTIMAX (TM) BILIARY CATHETER | Applied Vascular | 1991-02-13 | Traditional | PDF ↗ |
| K905707 | BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS | Baxter Healthcare Corp | 1991-02-13 | Traditional | PDF ↗ |
| K905714 | ERCP CANNULA | Everest Medical Corp. | 1991-02-01 | Traditional | PDF ↗ |
| K905229 | LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS | Arrow Intl., Inc. | 1991-01-18 | Traditional | PDF ↗ |
| K900923 | ZIMMON ENDOSCOPIC PANCREATIC STENT | Wilson-Cook Medical, Inc. | 1990-10-26 | Traditional | PDF ↗ |
| K903420 | SOEHENDRA STENT RETRIEVER | Wilson-Cook Medical, Inc. | 1990-10-22 | Traditional | PDF ↗ |
| K903858 | COOK-GIANTURCO ROSCH BILIARY Z-STENT, MODIFICATION | Cook, Inc. | 1990-10-10 | Traditional | PDF ↗ |
| K902734 | PR CANNULAS | Olympus Corp. | 1990-08-22 | Traditional | PDF ↗ |
| K902107 | WILSON-COOK SYRINGE HOLDERS | Wilson-Cook Medical, Inc. | 1990-07-16 | Traditional | PDF ↗ |
| K901582 | DOBBHOFF BILIARY STENT SET | Biosearch Medical Products, Inc. | 1990-06-22 | Traditional | PDF ↗ |
| K901427 | BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON | Telemed Systems, Inc. | 1990-06-22 | Traditional | PDF ↗ |
| K901433 | SURE-FLEX ANASTOMOTIC BALLOON DILATOR | Telemed Systems, Inc. | 1990-06-21 | Traditional | PDF ↗ |
| K901432 | BILIARY BALLOON DILATOR | Telemed Systems, Inc. | 1990-06-21 | Traditional | PDF ↗ |
| K901431 | TELEMED ERCP CANNULA | Telemed Systems, Inc. | 1990-06-18 | Traditional | PDF ↗ |
| K900904 | CANDELA DIRECTABLE BILIARY CATHETER SYSTEM | Candela Laser Corp. | 1990-05-11 | Traditional | PDF ↗ |
| K896323 | WILSON-COOK ENDOSCOPIC NASAL BILIARY DRAINAGE SETS | Wilson-Cook Medical, Inc. | 1990-04-09 | Traditional | PDF ↗ |
| K896391 | BARD/ANGIOMED STENTS | C.R. Bard, Inc. | 1990-03-29 | Traditional | PDF ↗ |
| K896518 | DOBBHOFF(R) ERCP CANNULA | Biosearch Medical Products, Inc. | 1990-02-02 | Traditional | PDF ↗ |
| K896503 | PORGES ERCP CATHETERS | Porges Corp. | 1990-01-30 | Traditional | PDF ↗ |
| K896506 | PORGES ENDOSCOPIC DORMIA EXTRACTORS, DORMIATRIPTOR | Porges Corp. | 1990-01-26 | Traditional | PDF ↗ |
| K896504 | PORGES 2-WAY BALLOON EXTRACTION CATHETER | Porges Corp. | 1990-01-26 | Traditional | PDF ↗ |
| K896423 | PORGES BILIARY STENTS | Porges Corp. | 1990-01-22 | Traditional | PDF ↗ |
| K896376 | PORGES NASOBILIARY DRAIN | Porges Corp. | 1990-01-22 | Traditional | PDF ↗ |
| K894867 | WILTEK E.R.C.P. CATHETER | Wiltek Medical, Inc. | 1989-12-21 | Traditional | PDF ↗ |
| K894871 | WILTEK BILIARY STENT SET | Wiltek Medical, Inc. | 1989-12-21 | Traditional | PDF ↗ |
| K896069 | WILSON-COOK GIANTURCO-ROSCH BILIARY Z STENT | Wilson-Cook Medical, Inc. | 1989-12-08 | Traditional | PDF ↗ |
| K896163 | SCHNEIDER STENT WALLSTENT ENDOSCOPIC BILIARY ENDO. | Schneider Stent | 1989-12-01 | Traditional | PDF ↗ |
| K884714 | BILIARY DIALATOR | Primrose Medical, Inc. | 1989-09-29 | Traditional | PDF ↗ |
| K892384 | BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER | Porges Corp. | 1989-05-04 | Traditional | PDF ↗ |
| K892383 | BILIARY ENDOPROSTHESIS FOR INTERNAL DRAINAGE SET | Porges Corp. | 1989-05-04 | Traditional | PDF ↗ |
| K880343 | BURNEY GALLBLADDER CATHETER KIT | Mallinckrodt Critical Care | 1989-05-01 | Traditional | PDF ↗ |
| K882610 | COOK-GIANTURCO BILIARY Z STENT | Cook, Inc. | 1989-04-21 | Traditional | PDF ↗ |
| K885180 | EXPANDABLE BILIARY STENT ENDOPROSTHESIS | Schneider Intl., Ltd. | 1989-02-16 | Traditional | PDF ↗ |
| K873606 | MODIFIED COPE SUTURE ANCHOR | Cook, Inc. | 1988-06-17 | Traditional | PDF ↗ |
| K873954 | NAMIC HAWKINS UNIVERSAL DRAINAGE SET | North American Instrument Corp. | 1988-01-29 | Traditional | PDF ↗ |
| K872509 | LINDEN STONE EXTRACTION BALLOON | Hobbs Medical, Inc. | 1987-09-22 | Traditional | PDF ↗ |
| K872458 | AN3200 DOUBILET DRAIN | H.W. Andersen Products, Inc. | 1987-09-21 | Traditional | PDF ↗ |
| K861291 | GASTROTOPO | Houston Biomedical, Inc. | 1987-05-15 | Traditional | PDF ↗ |
| K862059 | SHEATH, ENDOSCOPE | Endovations | 1986-11-04 | Traditional | PDF ↗ |
| K863571 | BILIARY BALLOON CATHETER | Uresil Corp. | 1986-11-04 | Traditional | PDF ↗ |
| K863437 | BARD BALLOON DILATATION SYSTEM | C.R. Bard, Inc. | 1986-10-29 | Traditional | PDF ↗ |
| K863957 | TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR GU | Cathaid, Inc. | 1986-10-24 | Traditional | PDF ↗ |
| K861220 | LUNDERQUIST - RING PTC DRAINAGE CATHETER | Meadox Surgimed, Inc. | 1986-05-19 | Traditional | PDF ↗ |
| K860990 | ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY | Endovations | 1986-05-13 | Traditional | PDF ↗ |
| K855142 | ANGIOMED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGTAPHY | Angiomed U.S., Inc. | 1986-03-11 | Traditional | PDF ↗ |
| K851962 | ZIMMON BILIARY STENT SET | Wilson-Cook Medical, Inc. | 1985-12-17 | Traditional | PDF ↗ |
| K851954 | PVL-4.8-200 BALLOON STONE EXTRACTOR | Wilson-Cook Medical, Inc. | 1985-12-17 | Traditional | PDF ↗ |
| K853666 | ENDODYNAMICS SIEGEL THERAPUTIC STENT | E-Z-Em, Inc. | 1985-11-05 | Traditional | PDF ↗ |
| K852293 | BARD-PARKER BILIARY BALLOON CATHETER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-10-04 | Traditional | PDF ↗ |
| K853543 | DAVOL RETRIEVAL BALLOON CATHETER | C.R. Bard, Inc. | 1985-09-20 | Traditional | PDF ↗ |
| K851242 | GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO | Cook, Inc. | 1985-09-11 | Traditional | PDF ↗ |
| K851960 | SOEHENDRA BILIARY DILATING CATHETER-SBDC-7 | Wilson-Cook Medical, Inc. | 1985-07-29 | Traditional | PDF ↗ |
| K851647 | OLBERT CATHETER SYSTEM FOR BILIARY TRACT DILATATIO | Meadox Surgimed, Inc. | 1985-07-03 | Traditional | PDF ↗ |
| K851956 | VPDS-1 VENNES PANCREATIC DILATION SET | Wilson-Cook Medical, Inc. | 1985-06-13 | Traditional | PDF ↗ |
| K844384 | BILIARY STENT PROSTHESIS | Mentor Corp. | 1985-02-14 | Traditional | PDF ↗ |
| K842147 | CATH-TECH CHOLANGIOGRAPHY CATHETER | Catheter Technology Corp. | 1984-10-02 | Traditional | PDF ↗ |
| K834413 | DILATION BALLOON CATHETER | Hobbs Medical, Inc. | 1984-05-22 | Traditional | PDF ↗ |
| K834468 | DRAINAGE STENT | Microvasive | 1984-04-20 | Traditional | PDF ↗ |
| K834574 | USCI ENDOPROSTHESIS | C.R. Bard, Inc. | 1984-04-05 | Traditional | PDF ↗ |
| K834351 | BILIARY INDWELLING STENT | Hobbs Medical, Inc. | 1984-03-22 | Traditional | PDF ↗ |
| K833937 | UMI PERCUTANEOUS TRANSHEPATIC CHOLAN | Universal Medical Instrument Corp. | 1984-01-03 | Traditional | PDF ↗ |
| K833920 | KELLY CHOLANGIOCATH | Perry, Div. | 1983-12-27 | Traditional | PDF ↗ |
| K830483 | COONS SOFT STENT | Medi-Tech, Inc. | 1983-03-09 | Traditional | PDF ↗ |
| K823428 | KELLY INFLATABLE T DRAIN | Akron Catheter, Inc. | 1983-01-18 | Traditional | PDF ↗ |
| K821819 | PIGTAIL STENTS | American Endoscopy, Inc. | 1982-08-20 | Traditional | PDF ↗ |
| K821817 | PIGTAIL NASAL CATHETERS | American Endoscopy, Inc. | 1982-08-10 | Traditional | PDF ↗ |
Product code FGE · Class II · Gastroenterology, Urology. Data: openFDA.