meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
44
Latest Decision
2005-03-08

Clearances · page 41 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K050304 FX WIRE ADVANCED MEASUREMENT GUIDEWIRE Conmedcorp OCY Class II 2005-03-08
K050403 SPYGLASS DIRECT VISULATION PROBE Boston Scientific Corp ODF Class II 2005-03-04
K043581 DUAL LUMEN CATHETER Acmi Corporation EYB Class II 2005-03-03
K043288 MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS Intuitive Surgical, Inc. NAY Class II 2005-03-03
K041884 MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS Mueller Water Conditioning, Inc. FIP Class II 2005-02-28
K043461 CUSTODIOL Dr. Franz Kohler Chemie GmbH KDL Class II 2005-02-28
K050253 USGI SHAPELOCK ENDOSCOPIC GUIDE Usgi Medical FED Class II 2005-02-28
K043284 ENDOASSIST Armstrong Healthcare Limited GCJ Class II 2005-02-25
K042110 BEAMCATH Beampoint AB EZL Class II 2005-02-25
K050103 XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM Abbott Laboratories FGE Class II 2005-02-16
K042659 MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS Medisiss NON Class I 2005-02-14
K033862 BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK Bioteque Corp. FGE Class II 2005-02-14
K043523 INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE Medical Device Technologies, Inc. KNW Class II 2005-02-11
K042834 MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR Micromedics, Inc. GCJ Class II 2005-02-11
K043254 PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH Onset Medical Corporation EZN Class II 2005-02-10
K050120 EASY CORE BIOPSY SYSTEM II Boston Scientific Corp FCG Class II 2005-02-08
K043605 INSCOPE 3-STAGE BALLOON DILATOR Cordis Europa, N.V. KNQ Class II 2005-02-04
K043126 ASSIST HEADER CLEANER Alcavis International, Inc. LIF Class II 2005-02-03
K042780 NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM Prosurg, Inc. FAJ Class II 2005-02-03
K040318 MEDCOMP SPLIT-CATH II Medcomp MSD Class II 2005-02-03
K042531 UPDATED SLIP UROLOGY INTRODUCER SHEATH Percutaneous Systems, Incorporated KNY Class II 2005-02-01
K042112 INFANT FEEDING TUBE Marian Medical, Inc. KNT Class II 2005-01-28
K043487 EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1 Aizu Olympus Co., Ltd. FDF Class II 2005-01-28
K050027 LAPAROCISION SCOPE CONTROLLER SYSTEM Gmp/Companies, Inc. GCJ Class II 2005-01-27
K050005 INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180 Intuitive Surgical, Inc. NAY Class II 2005-01-25
K042594 VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS Vanguard Medical Concepts, Inc. NON Class I 2005-01-25
K042709 DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER Tyco Healthcare EZL Class II 2005-01-18
K042938 GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS Gambro Renal Products KDI Class II 2005-01-06
K033210 BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET Bioteque Corp. FAD Class II 2004-12-30
K043481 MODIFICATION TO: ZILVER 635 BILIARY STENT Cook, Inc. FGE Class II 2004-12-29
K043241 LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER Astra Tech, Inc. GBM Class II 2004-12-23
K042985 LIFESTENT NT35 BILIARY STENT SYSTEM Edwards Lifesciences, LLC FGE Class II 2004-12-23
K043272 PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP Kendall MSD Class II 2004-12-22
K043244 FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR Fresenius Medical Care North America KDI Class II 2004-12-20
K040049 THE RELIANCE ENDOSCOPE PROCESSING SYSTEM STERIS Corporation NZA Class II 2004-12-17
K042923 MD-6W WIRELESS CRITICAL DATA VIEWER The Microoptical Corporation GCJ Class II 2004-12-17
K041987 CORTRAK Viasys Medsystems KNT Class II 2004-12-17
K043258 MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-02 Teleflex Medical KNT Class II 2004-12-16
K043153 INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS, MODELS IS1200 & IS1000 Intuitive Surgical, Inc. NAY Class II 2004-12-15
K043114 KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE Kimberly-Clark Corp. KNT Class II 2004-12-10
K043243 PRIMUS STENT AND DELIVERY SYSTEM Ev3, Inc. FGE Class II 2004-12-09
K042322 STERICHEK BLOOD LEAK REAGENT STRIPS Hach Company FJD Class II 2004-12-07
K043193 BARD INLAYOPTIMA URETERAL STENT WITH SUTURE C.R. Bard, Inc. FAD Class II 2004-12-07
K042858 55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS Spire Biomedical, Inc. MSD Class II 2004-12-03
K042427 GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER Genemed, Inc. LNS Class II 2004-12-03
K043027 MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20 Applied Medical Technology, Inc. KNT Class II 2004-12-02
K042089 NX STAGE WATER PURIFICATION SYSTEM Nxstage Medical, Inc. FIP Class II 2004-11-24
K042043 FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 Fujinon, Inc. FDS Class II 2004-11-24
K042960 GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO Given Imaging , Ltd. NSI Class II 2004-11-24
K040328 15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER Medcomp MSD Class II 2004-11-24
K042076 FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5 Fujinon, Inc. FDT Class II 2004-11-18
K041983 OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016 Opticon Medical EZL Class II 2004-11-17
K042877 MICROVERTER URETERAL ACCESS SHEATH Percutaneous Systems, Inc. KNY Class II 2004-11-16
K040660 STERICHEK GLUTARALDEHYDE REAGENT STRIPS Hach Company LIF Class II 2004-11-15
K042855 INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT Intuitive Surgical, Inc. NAY Class II 2004-11-12
K041967 GENICON SUCTION IRRIGATION SYSTEM Genicon GCJ Class II 2004-11-12
K041903 FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5 Fujinon, Inc. FDF Class II 2004-11-10
K042882 ENTERYX INJECTION CATHETER Boston Scientific Corp FBK Class II 2004-11-09
K042969 MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. FGE Class II 2004-11-08
K042566 VASC-ALERT Vasc-Alert, Inc. MQS Class II 2004-11-08
K042753 MAMMOTOME MR BIOPSY SYSTEM Ethicon Endo-Surgery, Inc. KNW Class II 2004-11-08
K041464 BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER Busse Hospital Disposables EZD Class II 2004-11-05
K042900 K.E.P. CONNECTOR AND CLIP K.E.P., LLC KDJ Class II 2004-11-05
K042615 CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE Carbon Medical Technologies, Inc. FBK Class II 2004-11-05
K042572 KENDALL CO2NFIRM NOW CO2 DETECTOR Kendall KNT Class II 2004-11-05
K040301 GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A Gambro Renal Products MPB Class II 2004-11-01
K042069 INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM Acmi Corporation GCJ Class II 2004-11-01
K040959 MENTOR GENESIS PENILE PROSTHESIS Mentor Corp. FAE Class II 2004-10-29
K041149 GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE Given Imaging , Ltd. NSI Class II 2004-10-25
K042457 URO PRO W.O.M. World of Medicine AG LJH Class II 2004-10-25
K042300 AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM Applied Medical Technology, Inc. KNT Class II 2004-10-25
K041912 SCB/VALLEYLAB FORCE FX INTERFACE UNIT KARL STORZ Endoscopy-America, Inc. ODA Class II 2004-10-25
K042224 RM3 RENAL PRESERVATION SYSTEM Waters Instruments, Inc. KDN Class II 2004-10-22
K031832 MEGA PURE CART Mega Services FIP Class II 2004-10-20
K042740 ISC-1000 PENTAX CONFOCAL LASER SYSTEM Pentax Medical Company GCJ Class II 2004-10-19
K042741 EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE Pentax Medical Company GCJ Class II 2004-10-19
K040760 MODIFICATION TO URETERAL STENT Applied Medical Resources Corp. FAD Class II 2004-10-15
K042561 TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER Fmd, LLC LNS Class II 2004-10-12
K041163 ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES Isopure, Corp. FIP Class II 2004-10-07
K041005 GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS Gambro Renal Products KDI Class II 2004-10-07
K042290 VACUUM ASSISTED CORE BIOPSY DEVICE Suros Surgical Systems, Inc. KNW Class II 2004-10-06
K031238 VARICES NEEDLE Scandimed. A.S. FBK Class II 2004-10-04
K042518 ZILVER 518 BILIARY STENT Cook, Inc. FGE Class II 2004-10-01
K041962 XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605 Abbott Laboratories FGE Class II 2004-10-01
K042464 V-CORE FULL CORE BREAST BIOPSY INSTRUMENT Medical Device Technologies, Inc. KNW Class II 2004-09-30
K040658 BARDEX I.C. LATEX FOLEY CATHETER C.R. Bard, Inc. MJC Class II 2004-09-29
K041914 PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER Kendall MSD Class II 2004-09-27
K042412 MODIFIED SPACEMAKER SYSTEM United States Surgical, A Division of Tyco Healthc GCJ Class II 2004-09-24
K041792 FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211 Fresenius Medical Care North America KDJ Class II 2004-09-24
K042016 DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER Datascope Corp. MSD Class II 2004-09-23
K041732 CAVERMAP SURGICAL AID Blue Torch Medical Technologies FGM Class I 2004-09-21
K033570 MEDCOMP T-3 Medcomp NIE Class II 2004-09-16
K041795 MODIFICATION TO OPTICAL SEPARATOR SYSTEM Applied Medical Resources Corp. GCJ Class II 2004-09-14
K041791 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) Chf Solutions, Inc. NQJ Class II 2004-09-10
K042225 ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 Acmi Corporation FAJ Class II 2004-09-10
K034021 VACUUM ASSISTED CORE BIOPSY DEVICE Suros Surgical Systems, Inc. KNW Class II 2004-09-08
K042136 SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM Sanarus Medical, Inc. KNW Class II 2004-09-08
K033132 STRYKER SWITCHPOINT INFINITY Stryker Communications Corp. GCJ Class II 2004-09-02
K041034 SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL) Entracare, LLC KNT Class II 2004-08-31
K042045 NXSTAGE PUREFLOW-B SOLUTION Nxstage Medical, Inc. KPO Class II 2004-08-27

11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.