meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
54
Latest Decision
2003-04-16

Clearances · page 45 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K030854 PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400 E-Z-Em, Inc. FCX Class II 2003-04-16
K030422 LINA-BAG, MODELS LB-60, LB-100 Lina Medical Cml Aps GCJ Class II 2003-04-14
K023308 LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS Orbus Medical Technologies FGE Class II 2003-04-14
K023872 VITALCARE URETHRAL CATHETER RED RUBBER Vitalcare, Inc. EZD Class II 2003-04-10
K030940 NOMAD ND1000M AUGMENTED VISION SYSTEM Microvision Incorporated GCJ Class II 2003-04-09
K030059 PORTABLE RO+ MODEL MROS09 Ameriwater FIP Class II 2003-04-07
K022112 FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020 Fortune Medical Instrument Corp. KNT Class II 2003-04-03
K030053 JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810 Jomed AG FGE Class II 2003-03-31
K030645 BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT Boston Scientific Corp FGE Class II 2003-03-25
K030194 XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT The Olympus Optical Co. KNS Class II 2003-03-24
K024301 LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT Lsi Solutions ODC Class II 2003-03-24
K030107 100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM Boston Scientific Corp FGE Class II 2003-03-21
K023162 FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS Fresenius Medical Care FIE Class II 2003-03-20
K023090 OPTION-VF URINARY CATHETER, FV14218 Opticon Medical, Inc. EZL Class II 2003-03-19
K024251 SIGHTFIX World of Medicine Lemke GmbH GCJ Class II 2003-03-18
K030503 MODIFICATION TO CONTOUR POLARIS URETERAL STENT Boston Scientific Corp FAD Class II 2003-03-17
K030438 BARD AQUAGUIDE URETERAL CONDUIT C.R. Bard, Inc. FED Class II 2003-03-17
K024124 SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT Chf Solutions, Inc. KDI Class II 2003-03-14
K024089 VACUFLASH BIOPSY SYSTEM Bip USA, Inc. KNW Class II 2003-03-11
K030538 AMERICAN CATHETER, MODEL W3 Catheter, LLC EZD Class II 2003-03-10
K030409 SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM Cordis Corp. FGE Class II 2003-03-10
K023121 LIFESTENT BILIARY ENDOPROSTHESIS Orbus Medical Technologies FGE Class II 2003-03-10
K023808 IRRIGATION SETS International Medsurg Connection LJH Class II 2003-03-10
K022412 FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR Fresenius Medical Care North America KDJ Class II 2003-03-05
K024015 REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS Alliance Medical Corp. NLM Class II 2003-03-04
K023985 ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE Rockwell Medical Technologies, Inc. KPO Class II 2003-02-28
K023690 CATHETER CONNECTOR World Metals, Inc. KNY Class II 2003-02-28
K022980 MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd. NEZ Class II 2003-02-27
K030315 MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM Ultroid, LLC KNS Class II 2003-02-27
K022678 MEDCOMP SC4 Medcomp MSD Class II 2003-02-24
K023664 SYNTRA + DIALYZER, MODEL 200 Baxter Healthcare Corp KDI Class II 2003-02-21
K030240 MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER Computer Motion, Inc. GCJ Class II 2003-02-21
K023903 WILSON-COOK ENDOSCOPIC CLIPPING DEVICE Wilson-Cook Medical, Inc. PKL Class II 2003-02-20
K023630 ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400 Guidant Corporation, Cardiac Surgery GCJ Class II 2003-02-20
K023906 PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM The Prometheus Group KPI Class II 2003-02-19
K023603 ENDO-GLIDE GUIDEWIRE Endo-Therapeutics, Inc. OCY Class II 2003-02-19
K023843 SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE Opus Medical, Inc. OCW Class II 2003-02-14
K023248 LIFESTENT LP SDS BILIARY ENDOPROSTHESIS Orbus Medical Technologies FGE Class II 2003-02-11
K022747 HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM Hydropure Systems, Inc. FIP Class II 2003-02-11
K023401 EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE Pentax Precision Instrument Corp. ODG Class II 2003-02-11
K022221 TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS Deltec, Inc. MPB Class II 2003-01-30
K023659 1-CCD ENDOCAM 5520 SYSTEM Richard Wolf Medical Instruments Corp. FET Class II 2003-01-29
K023254 SPEEDICATH Coloplast Corp. GBM Class II 2003-01-27
K022447 BARD ER URETERAL STENT WITH SUTURE C.R. Bard, Inc. FAD Class II 2003-01-23
K010714 EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830 Medi-Globe Corp. FGE Class II 2003-01-21
K023535 TRIPTER X-1 COMPACT DUET Direx Systems Corp. LNS Class II 2003-01-17
K024120 MODIFICATION TO TEMNO BIOPSY NEEDLES Allegiance Healthcare Corp. FCG Class II 2003-01-15
K023706 ULTROID HEMORRHOID MANAGEMENT SYSTEM Ultroid, LLC KNS Class II 2003-01-14
K023468 ENDOSCOPIC LIGHT SOURCE XL180/L3 World of Medicine Lemke GmbH GCT Class II 2003-01-14
K024294 MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER Computer Motion, Inc. GCJ Class II 2003-01-08
K022023 COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500 Clinical Innovations, Inc. KLA Class II 2003-01-07
K024048 MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM Boston Scientific Scimed, Inc. FGE Class II 2003-01-06
K020924 CUSTODIOL HTK SOLUTION Dr. Franz Kohler Chemie GmbH KDL Class II 2003-01-06
K023358 USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8 Acmi Corporation FGB Class II 2003-01-03
K022521 BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON Rockwell Medical Technologies, Inc. KPO Class II 2003-01-03
K021994 BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM C.R. Bard, Inc. FGE Class II 2003-01-02
K023633 SOVIS OPTIQUE'S ENDOSCOPIC CABLE Sovis Optique FFS Class II 2002-12-31
K023259 INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 Helix Medical, Inc. FDF Class II 2002-12-26
K022086 AIM-V (R) MEDIUM, MODEL 087-0112 Invitrogen Corporation NDS Class II 2002-12-23
K021775 LTFS230 Healthtronics, Inc. LNS Class II 2002-12-23
K023272 DISPOSABLE ASPIRATION NEEDLE NA-200H The Olympus Optical Co. FCG Class II 2002-12-23
K022500 DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE Rockwell Medical Technologies, Inc. KPO Class II 2002-12-23
K024033 XTJF-160AF DUODENOVIDEOSCOPE Olympus Optical Co., Ltd. FDT Class II 2002-12-20
K013113 MODIFICATION TO NANMA VACUUM PUMP Nanma Mfg Co., Ltd. LKY Class II 2002-12-20
K023870 FLEXIMA BILIARY CATHETER Boston Scientific/Medi-Tech FGE Class II 2002-12-20
K024011 SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES Surgical Instruments Service and Savings, Inc. NLU Class II 2002-12-19
K014215 VIABIL BILIARY ENDOPROSTHESIS W. L. Gore & Associates, Inc. FGE Class II 2002-12-19
K023907 CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER Cordis Corp. KNQ Class II 2002-12-18
K023243 MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY Sulzer Intratherapeutics, Inc. FGE Class II 2002-12-13
K022905 LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER Horizon Medical Products, Inc. MSD Class II 2002-12-13
K023261 ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244 Taut, Inc. GCJ Class II 2002-12-13
K013562 AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE Baxter Healthcare Corp KDI Class II 2002-12-12
K014152 NXSTAGE CARTRIDGE EXPRESS Nxstage Medical, Inc. KDI Class II 2002-12-11
K023923 SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE Senorx, Inc. KNW Class II 2002-12-11
K023019 VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000 Vomed Volzer Medizintechnik GmbH & Co. FGI Class II 2002-12-10
K022963 TRANSONIC SYRINGE WARMER, MODEL SYR-1000 Transonic Systems, Inc. MQS Class II 2002-12-04
K022686 LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE Lap Surgical Systems, LLC FED Class II 2002-11-25
K014269 POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102 Medtronic Functional Diagnostics A/S MYE Class II 2002-11-21
K014140 RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET Sunder Biomedical Tech. Co., Ltd. FJK Class II 2002-11-18
K021615 BAXTER ACCURA SYSTEM, MODEL 5M5660 Baxter Healthcare Corp KDI Class II 2002-11-18
K023095 HERMES OPERATING ROOM CONTROL CENTER Computer Motion, Inc. GCJ Class II 2002-11-15
K021060 FRESENIUS ICARE MONITORING SYSTEM Fresenius Medical Care North America FKP Class II 2002-11-13
K022574 INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM & ENDOSCOPIC INSTRUMENTS, MODEL DA VINCI ISI 1000/1200 Intuitive Surgical, Inc. NAY Class II 2002-11-12
K023627 ESSEX ENDOSCOPE, MODEL SXD-1000 Guidant Corp. GCJ Class II 2002-11-12
K023629 ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200 Guidant Corporation, Cardiac Surgery GCJ Class II 2002-11-12
K011471 BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER Medtronic Functional Diagnostics A/S FFX Class II 2002-11-08
K022644 RETRO REPAIR KIT, MODEL PRRK5 Spire Biomedical, Inc. NFK Class II 2002-11-06
K023344 INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE Bowel Management Systems, LLC KNT Class II 2002-11-06
K021732 DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT Dideco S.P.A. KDI Class II 2002-11-04
K022751 REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS Medical Device Services KGE Class II 2002-11-04
K011005 PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS Pure Water Solutions, Inc. FIP Class II 2002-11-01
K022570 MEDCOMP REPAIR KIT, MODEL ASPCRPK Medcomp NFK Class II 2002-10-31
K022536 \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR Fresenius Medical Care KOC Class II 2002-10-30
K021630 BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM Boston Scientific Corp FGE Class II 2002-10-25
K023217 MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. FGE Class II 2002-10-25
K022243 HORIZONS REUSABLE HOT BIOPSY FORCEPS Horizons Intl. Corp. KGE Class II 2002-10-25
K022484 COOK INJECTION NEEDLE Cook Urological, Inc. FBK Class II 2002-10-25
K022268 HORIZONS REUSABLE POLYPECTOMY SNARES Horizons Intl. Corp. FDI Class II 2002-10-25
K023224 INFUSION CATHETER EXTENSION SET Chf Solutions, Inc. KDI Class II 2002-10-25
K022913 NXSTAGE PREMIXED DIALYSATE Nxstage Medical, Inc. KPO Class II 2002-10-21

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