Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 50
- Latest Decision
- 2000-08-24
Clearances · page 51 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K001666 | MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM | Intuitive Surgical, Inc. | GCJ | Class II | 2000-08-24 |
| K001633 | LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 & LHCEK0000 | Vasca, Inc. | MSD | Class II | 2000-08-24 |
| K001325 | FLO ASSISTANT, MODEL 4-250-00 | Northgate Technologies, Inc. | LJH | Class II | 2000-08-18 |
| K002018 | NDO SURGICAL SURGICAL OVERTUBE | Surgical, Inc. | FED | Class II | 2000-08-17 |
| K001250 | APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) | Asahi Medical Co., Ltd. | KDI | Class II | 2000-08-16 |
| K993806 | DIALGUARD ENDOTOXIN REMOVAL DEVICE | Clarigen, Inc. | FIP | Class II | 2000-08-14 |
| K994231 | SIEMENS INTEGRATED OPERATING SYSTEM (SIOS) | Siemens Medical Corp. | ODA | Class II | 2000-08-10 |
| K000388 | CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL) | Clearwater Colon Hydrotherapy, Inc. | KPL | Class II | 2000-08-08 |
| K994109 | DETRUSAN 500 | Innovamed USA, Inc. | KPI | Class II | 2000-08-03 |
| K001496 | A.V. FISTULA NEEDLE | Exelint International, Co. | FIE | Class II | 2000-08-01 |
| K001515 | PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000 | The Prometheus Group | KPI | Class II | 2000-07-31 |
| K002101 | ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER | AngioDynamics, Inc. | FGE | Class II | 2000-07-31 |
| K002323 | ADVANCED UROSCIENCE INJECTION NEEDLE | Advanced Uroscience, Inc. | FBK | Class II | 2000-07-31 |
| K001873 | HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0 | Fresenius Medical Care North America | FJK | Class II | 2000-07-28 |
| K990365 | GASTRIC LAVAGE VALVE | T-Med Vac Corporation | KNT | Class II | 2000-07-26 |
| K993909 | NANMA VACUUM PUMP | Nanma Mfg Co., Ltd. | LKY | Class II | 2000-07-19 |
| K002084 | MICROVASIVE LITHOTRIPTOR FLEXPROBE II | Boston Scientific Corp | FFK | Class II | 2000-07-19 |
| K001843 | S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Cordis Corp. | FGE | Class II | 2000-07-18 |
| K992182 | CA GUARD, LTD. PSP (PORT SITE PROTECTOR) | Ca Guard, Ltd. | GCJ | Class II | 2000-07-18 |
| K001362 | KARL STORZ 3D VIDEO SYSTEM | Karl Storz Imaging, Inc. | GCI | Class II | 2000-07-17 |
| K001328 | INTRODUCER SHEATH | Novasys Medical, Inc. | FEC | Class II | 2000-07-17 |
| K001386 | ACCUSET SENSOR, MODEL 2000 | Pelvicare, Inc. | FEN | Class II | 2000-07-17 |
| K001698 | MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159 | Cogent Light Technologies, Inc. | FFS | Class II | 2000-07-17 |
| K001236 | RIZA BAND STRETCHER (RBS)-60000 | R-Med, Inc. | FHN | Class II | 2000-07-17 |
| K001583 | ISLAND BIOSURGICAL BNS KIT #3 | Island Biosurgical, LLC | KOD | Class II | 2000-07-13 |
| K001217 | INSIDE VIEW | Monadnock Optics, Inc. | GCM | Class II | 2000-07-11 |
| K001194 | STERICHEK TOTAL CHLORINE REAGENT STRIPS | Environmental Test Systems, Inc. | MSY | Class II | 2000-07-11 |
| K990144 | INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM | Intuitive Surgical, Inc. | NAY | Class II | 2000-07-11 |
| K000124 | SENSATION -VACUUM ASSIST DEVICES | Prosurg, Inc. | LKY | Class II | 2000-07-10 |
| K001143 | RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER | Rochester Medical Corp. | MJC | Class II | 2000-07-07 |
| K001156 | PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET | Gambro Renal Products | KDI | Class II | 2000-07-07 |
| K001059 | NORMOCARB STERILE BICARBONATE RENAL DIALYSIS | Novex Pharma | KPO | Class II | 2000-06-30 |
| K001146 | GENYX FLEXIBLE INJECTION NEEEDLE | Geny Medical, Inc. | FBK | Class II | 2000-06-30 |
| K994130 | RECTOSIGHT RS 300-04 | Sightline Technologies , Ltd. | FER | Class II | 2000-06-30 |
| K001258 | BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM | Cordis Corp. | FGE | Class II | 2000-06-27 |
| K001107 | FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP) | Fresenius Medical Care North America | FJK | Class II | 2000-06-23 |
| K001594 | 3.5 MM LAPAROSCOPE (LG100, LG103) | Surgical Image Laboratories, Inc. | GCJ | Class II | 2000-06-12 |
| K000792 | CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX | Advanced Renal Technologies, Inc. | KPO | Class II | 2000-06-08 |
| K000702 | BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR | Fresenius Medical Care North America | FIB | Class II | 2000-06-07 |
| K000767 | MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201 | Memcath Technologies, LLC | KNY | Class II | 2000-06-05 |
| K001597 | CONMED TROGARD FINESSE TROCAR SYSTEM, MODEL 60-6050-XXX | Conmedcorp | GCJ | Class II | 2000-06-05 |
| K994223 | NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20 | Richard Wolf Medical Instruments Corp. | FGA | Class II | 2000-06-05 |
| K000744 | MEDTRONIC AVE BRIDGE X3 STENT | Medtronic Ave, Inc. | FGE | Class II | 2000-06-05 |
| K001422 | PSN HEMODIALYZER, MODELS PSN 170, PSN 210 | Baxter Healthcare Corp | KDI | Class II | 2000-06-02 |
| K000769 | KSEA MANHES PNEUMOTROCAR | KARL STORZ Endoscopy-America, Inc. | GCJ | Class II | 2000-06-01 |
| K001264 | EAGLE ENDO SPECIMEN RETRIEVAL BAG | Eagle Endoscopic, Inc. | GCJ | Class II | 2000-05-30 |
| K000669 | MEDIVISION I-VIEW PERSONAL VIDEO DISPLAY | Medivision Endoscopy | GCJ | Class II | 2000-05-26 |
| K993877 | NELSON WATER SYSTEMS FOR HEMODIALYSIS | Nelson Environmental Technologies, Inc. | FIP | Class II | 2000-05-25 |
| K000308 | WALLSTENT BILIARY ENDOPROSTHESIS | Boston Scientific Corp | FGE | Class II | 2000-05-19 |
| K000723 | HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC) | Rochester Medical Corp. | KOD | Class II | 2000-05-19 |
| K001222 | OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1 | Guidant Corp. | FGE | Class II | 2000-05-17 |
| K001224 | RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100 | Guidant Corp. | FGE | Class II | 2000-05-17 |
| K001169 | OPTIVU HDVD SYSTEM | Optimize, Inc. | GCJ | Class II | 2000-05-16 |
| K000493 | STRYKER IRRIGATION TUBE SET | Stryker Endoscopy | GCJ | Class II | 2000-05-15 |
| K000905 | URETHROTOME 8667.XXX AND 8670.XXX | Richard Wolf Medical Instruments Corp. | EZO | Class II | 2000-05-12 |
| K000948 | OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1 | Keymed (Medical & Industrial Equipment), Ltd. | FEQ | Class II | 2000-05-12 |
| K000216 | PSK ENDOSCOPE CLEANING SYSTEM | Psk Connectors Pty, Ltd. | FEB | Class II | 2000-05-09 |
| K000451 | FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290 | Fresenius Medical Care North America | FJK | Class II | 2000-05-09 |
| K001241 | EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I | The Olympus Optical Co. | FDF | Class II | 2000-05-09 |
| K000416 | TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001 | Retinalabs.Com | MPA | Class II | 2000-05-08 |
| K000386 | POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111 | Medtronic Functional Diagnostics A/S | FFX | Class II | 2000-05-05 |
| K993520 | H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS | Serv-A-Pure Co. | FIP | Class II | 2000-05-03 |
| K000545 | SENTRY EXPANDING INTRODUCER SHEATH (EIS) | Applied Medical Resources | GCJ | Class II | 2000-05-02 |
| K000663 | KRONNER LOW PROFILE SCOPE HOLDER | Kronner Prototypes, Inc. | GCJ | Class II | 2000-05-02 |
| K001132 | BONE BIOPSY NEEDLE | Promex, Inc. | KNW | Class II | 2000-05-01 |
| K001270 | GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE | Gyrus Medical , Ltd. | FJL | Class II | 2000-04-28 |
| K993149 | PERITONEAL DIALYSIS CATHETERS AND ADAPTERS | Medionics International, Inc. | FJS | Class II | 2000-04-28 |
| K000297 | ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER | Erchinger Medizintecnik | FHN | Class II | 2000-04-24 |
| K000612 | ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE | Inrad | KNW | Class II | 2000-04-24 |
| K000508 | THERMOFLEX SYSTEM | Argomed, Inc. | KNS | Class II | 2000-04-18 |
| K991908 | IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS | Idemsa | FJI | Class II | 2000-04-17 |
| K991519 | AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS | Ameriwater | FIP | Class II | 2000-04-14 |
| K000864 | INTRASTENT DOUBLESTRUT XS STENT | Intratherapeutics, Inc. | FGE | Class II | 2000-04-14 |
| K000646 | DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE | Enteric Medical Technologies | FBK | Class II | 2000-04-13 |
| K000337 | MTP DISPOSABLE TROCAR VALVES | Mtp Medical Technical Promotion GmbH | GCJ | Class II | 2000-04-12 |
| K000793 | 1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER | Guidant Corp. | FGE | Class II | 2000-04-12 |
| K000843 | MODIFICATION TO JMS APHERESIS NEEDLE | Jms Co., Ltd. | FIE | Class II | 2000-04-10 |
| K993272 | PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM | Pure Water, Inc. | FIN | Class II | 2000-04-10 |
| K000135 | PRO.DUCT CATHETER, MODEL CTH03 | Pro. Duct Health, Inc. | KNW | Class II | 2000-04-10 |
| K000845 | MODIFICATION TO JMS A.V. FISTULA NEEDLE SET | Jms Co., Ltd. | FIE | Class II | 2000-04-10 |
| K000028 | RENAFLO II HF 2000 HEMOFILTER | Minntech Corp. | KDI | Class II | 2000-04-04 |
| K000424 | S51D DIGITAL ENDOSCOPY CAMERA | Sopro | GCJ | Class II | 2000-03-31 |
| K000202 | CORTEK LAPAROSCOPES | Cortek Endoscopy, Inc. | GCJ | Class II | 2000-03-31 |
| K000423 | S52D DIGITAL VIDEO LAPAROSCOPE | Sopro | GCJ | Class II | 2000-03-31 |
| K000422 | S57D DIGITAL OPERATING ROOM CAMERA | Sopro | GCJ | Class II | 2000-03-31 |
| K000717 | SMITH & NEPHEW SUTURELOK, MODEL 7207321 | Smith & Nephew, Inc. | OCW | Class II | 2000-03-30 |
| K993041 | OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT | The Olympus Optical Co. | FAJ | Class II | 2000-03-30 |
| K000564 | CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY | Cordis Corp. | FGE | Class II | 2000-03-23 |
| K993303 | SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER | Boston Scientific Corp | FGE | Class II | 2000-03-23 |
| K994226 | STERICHEK TOTAL CHLORINE REAGENT STRIPS | Environmental Test Systems, Inc. | MSY | Class II | 2000-03-22 |
| K000229 | VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE | Videolabs, Inc. | FCW | Class II | 2000-03-21 |
| K994306 | REVERSO | Medisystems Corp. | KOC | Class II | 2000-03-20 |
| K993343 | ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS | Erecxel Enterprises | LKY | Class II | 2000-03-20 |
| K994290 | BARD ENDOSCOPIC SUTURING SYSTEM | C.R. Bard, Inc. | ODE | Class II | 2000-03-20 |
| K000550 | OTW MEGALINK SDS BILIARY STENT SYSTEM | Advanced Cardiovascular Systems, Inc. | FGE | Class II | 2000-03-17 |
| K994267 | FRESENIUS 2008K | Fresenius Medical Care | KDI | Class II | 2000-03-16 |
| K000086 | WILSON-COOK REUSABLE HOT BIOPSY FORCEPS | Wilson-Cook Medical, Inc. | KGE | Class II | 2000-03-15 |
| K993358 | SIGHTSURE OPERATION INDICATOR, MODEL SS301 | Medevices, Inc. | KNT | Class II | 2000-03-15 |
| K000397 | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL | Boston Scientific Corp | FHN | Class II | 2000-03-07 |
| K000200 | CORTEK URETHEROSCOPE | Cortek Endoscopy, Inc. | FGB | Class II | 2000-03-03 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.