meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
41
Latest Decision
2002-05-06

Clearances · page 47 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K020379 PPD BALLOON DILATATION CATHETER Telemed Systems, Inc. KNT Class II 2002-05-06
K012113 INDWELLING FECAL MANAGEMENT SYSTEM Bowel Management Systems, LLC KNT Class II 2002-05-03
K020341 GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd. NEZ Class II 2002-05-02
K021074 VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA Olympus America, Inc. FAJ Class II 2002-05-02
K013471 DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER E.S.W.L. Products, Inc. LNS Class II 2002-04-29
K012556 REPROCESSED GUIDEWIRES Sterilmed, Inc. NML Class II 2002-04-29
K020307 LAP DISC 120 X 120MM X 2CM #LD111; LAP DISC 120 X 120MM X 7CM #LD112 Hakko Shoji Co., Ltd. GCJ Class II 2002-04-26
K020230 DIASOL-BICARB Diasol, Inc. KPO Class II 2002-04-23
K020858 NXSTAGE THERAPY SYSTEM Nxstage Medical, Inc. KDI Class II 2002-04-17
K011793 KSEA FIBERSCOPE KARL STORZ Endoscopy-America, Inc. LYK Class II 2002-04-17
K020528 INTRASTENT LD (LARGE DIAMETER) STENT Sulzer Intratherapeutics, Inc. FGE Class II 2002-04-16
K020824 SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238 Boston Scientific Corp FHN Class II 2002-04-12
K020809 MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT Cordis Corp. FGE Class II 2002-04-12
K013160 POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER Spire Biomedical, Inc. MSD Class II 2002-04-11
K020089 MAHURKAR TRIPLE LUMEN CATHETER, 12 FR The Kendall Company NIE Class II 2002-04-10
K012758 URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L, Circon Video FGB Class II 2002-04-09
K013108 BIOSUC Hakko Medical Co., Ltd. KNW Class II 2002-04-04
K020258 SUPPORT SLEEVE Pos-T-Vac, Inc. LKY Class II 2002-04-04
K020154 VT-1 Pos-T-Vac, Inc. LKY Class II 2002-04-04
K020024 CARIS MINITOME BIOPSY INSTRUMENT Artemis Medical, Inc. KNW Class II 2002-04-03
K020682 BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM C.R. Bard, Inc. FGE Class II 2002-04-02
K020702 O'REGAN DISPOSABLE ANOSCOPE Canadian Theatre Products , Ltd. FER Class II 2002-03-29
K013551 ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM Computer Motion, Inc. GCJ Class II 2002-03-28
K010131 PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB Aksys, Ltd. KDI Class II 2002-03-26
K020310 DAVLITE MICROENDOSCOPE & ACCESSORIES Davlite Technologies GCJ Class II 2002-03-20
K020526 MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR Don Wilson/Wilson-Cook Medical, Inc. FHN Class II 2002-03-19
K020336 ENDOSCOPIC CAMERA MC404/C3 World of Medicine Lemke GmbH GCJ Class II 2002-03-14
K014158 ENDOSCOPIC CAMERA TC804/C4 World of Medicine Lemke GmbH GCJ Class II 2002-03-14
K020270 SOPRO 367D 3CCD FULL DIGITAL ENDOSCOPY CAMERA Sopro GCJ Class II 2002-03-14
K013109 SONOPSY Hakko Medical Co., Ltd. FCG Class II 2002-03-12
K013677 MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM Usfilter/Ionpure, Inc. FIP Class II 2002-03-08
K020428 ENDOPATH DILATING TIP TROCAR, MODEL #512XD Ethicon Endo-Surgery, Inc. GCJ Class II 2002-03-04
K011269 LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR Nxstage Medical, Inc. KDI Class II 2002-03-04
K014002 ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 Fortune Medical Instrument Corp. KOB Class II 2002-03-04
K013737 MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON Telemed Systems, Inc. FGE Class II 2002-03-01
K014047 APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE Applied Medical Resources Corp. GCJ Class II 2002-02-28
K013951 SANDHILL SCIENTIFIC PEDIATEC PH PROBE Sandhill Scientific, Inc. FFT Class I 2002-02-28
K013952 INTUITIVE SURGICAL STERO VIEW ENDOSCOPIC SYSTEM Intuitive Surgical, Inc. GCJ Class II 2002-02-28
K010798 RUSCH CANTOR TUBE Rusch Intl. KNT Class II 2002-02-26
K010797 RUSCH MILLER-ABBOTT TUBE Rusch Intl. KNT Class II 2002-02-26
K013360 DFINER UROLOGICAL CATHETER Neoseed Technology,Llc FGI Class II 2002-02-20
K013219 PROTOCO2L INSUFFLATOR MODEL 6400 E-Z-Em, Inc. FCX Class II 2002-02-19
K014005 APPLE MEDICAL MOBIUS ELASTIC RETRACTOR Apple Medical Corp. GCJ Class II 2002-02-15
K013276 ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE) Sewoon Medical Co., Ltd. EZL Class II 2002-02-15
K012581 REPROCESSED STONE RETRIEVAL BASKETS Sterilmed, Inc. FFL Class II 2002-02-14
K012685 REPROCESSED ENDOSCOPIC ELECTRODES Sterilmed, Inc. NLW Class II 2002-02-14
K013872 RUSCH MEMORY BAG Rusch Intl. GCJ Class II 2002-02-12
K020301 MODIFICATION TO VISTA STEREOSCOPE SYSTEM Vista Medical Technologies, Inc. FET Class II 2002-02-12
K020052 SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. FGE Class II 2002-02-11
K011106 STONELITH, MODEL V5 Pck Electronic Industry and Trade Co, Ltd. LNS Class II 2002-02-11
K012562 MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER Medical Components, Inc. MSD Class II 2002-02-08
K013889 ENDOSCOPIC MULTI-FIRE CLIP APPLIER Inscope, LLC PKL Class II 2002-02-07
K014169 WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS Bob J. Johnson & Assoc., Inc. FIP Class II 2002-02-06
K002102 GENTLE COLONICS IRRIGATION SYSTEM Gentle Colonics, Inc. KPL Class II 2002-02-06
K020082 ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM Endocare, Inc. LKY Class II 2002-02-05
K013692 TRAPSYSTEM SET H.S. Hospital Service S.R.L. KNW Class II 2002-02-05
K013701 ENDO-GLIDE Sonotech, Inc. GCJ Class II 2002-02-04
K012502 MEDIGROUP CATHETER EXTENDER/REPAIR KIT Janin Group, Inc. FJS Class II 2002-02-04
K013640 EG-3630UR, ULTRASUND VIDEO GASTROSCOPE Pentax Precision Instrument Corp. FDS Class II 2002-02-04
K013655 NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100 Nxstage Medical, Inc. KPO Class II 2002-02-04
K013611 HENKE SASS WOLF SAPHENOUS VEIN LAPAROSCOPE Henke Sass Wolf of America, Inc. GCJ Class II 2002-02-01
K013617 LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS Olympus Optical Co., Ltd. GCJ Class II 2002-01-30
K013575 KPS-I, THE KIDNEY PERFUSION SOLUTION Organ Recovery Systems, Inc. KDN Class II 2002-01-25
K013576 PERICSCOPE, MODEL # PERISC1 Ethicon Endo-Surgery, Inc. GCJ Class II 2002-01-25
K012328 HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER Di-Chem, Inc. KPO Class II 2002-01-18
K014184 MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM Guidant Corp. FGE Class II 2002-01-18
K010549 BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS) Medi-Globe Corp. FGE Class II 2002-01-18
K012547 HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION Di-Chem, Inc. KPO Class II 2002-01-18
K013165 USA SERIES LAPAROSCOPES Circon Acmi GCJ Class II 2002-01-18
K012884 DILATING TIP OBTURATOR Applied Medical Resources Corp. GCJ Class II 2002-01-17
K014136 MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY Sulzer Intratherapeutics, Inc. FGE Class II 2002-01-17
K013448 PRISMASATE Gambro Renal Products KPO Class II 2002-01-15
K013483 INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT Hollister, Inc. KOD Class II 2002-01-14
K014205 MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE) Medtronic Ave, Inc. FGE Class II 2002-01-14
K003311 NUTRISAFE PUR ENTERAL FEEDING TUBE Vygon Corp. FPD Class II 2002-01-11
K014250 7MM EXTENDED LENGTH ENDOSCOPE,DISSECTION TIPS, MODELS VH-1111, VH-1114 Guidant Corp. GCJ Class II 2002-01-10
K010033 LIGHT PROJECTOR WITH ENDOSCOPIC CAMERA, 1 CCD CAMERA HEAD NTSC, 1 CCD CAMERA HEAD PAL, LIGHT PROJECTOR, MODEL 5551.107 Richard Wolf Medical Instruments Corp. GCJ Class II 2002-01-10
K013724 BICART Gambro Renal Products KPO Class II 2002-01-08
K013695 MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10 Microline Pentax, Inc. GCJ Class II 2002-01-08
K013345 INCARE INTERMITTENT CATHETER Hollister, Inc. KOD Class II 2002-01-07
K014007 DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM Guidant Corp. FGE Class II 2002-01-07
K011537 DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFS Dynamic Technology Corp. KDI Class II 2002-01-07
K013384 SHARGHP A.V. FISTULA NEEDLE SET Shargh Pharmaceutical Co., Inc. FIE Class II 2002-01-07
K013174 PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL, Porges S.A. EZL Class II 2002-01-04
K013172 PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL Porges S.A. EZL Class II 2001-12-20
K012660 GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES Gimmi GmbH FET Class II 2001-12-20
K013141 MICROGYN PLUS STIMULATION DEVICE Hollister, Inc. KPI Class II 2001-12-19
K012088 NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT Nastech Pharmaceutical Company, Inc. KNW Class II 2001-12-18
K013090 SOPRO 67D OPERATING ROOM CAMERA Sopro GCJ Class II 2001-12-13
K013071 SECURCUT ASPIRATION BIOPSY NEEDLE H.S. Hospital Services S.P.A. FCG Class II 2001-12-12
K013069 BIOSPEED H.S. Hospital Services S.P.A. FCG Class II 2001-12-12
K013070 JAMSHIDI BIOPSY NEEDLE H.S. Hospital Services S.P.A. FCG Class II 2001-12-12
K013066 HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE Olympus America, Inc. MND Class II 2001-12-11
K012587 RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE Vidamed, Inc. KNS Class II 2001-12-11
K013804 SOCRATES ROBOTIC TELEMONITORING SYSTEM Computer Motion, Inc. NEQ Class II 2001-12-10
K011849 MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS Circon Video FGB Class II 2001-12-10
K013037 EXCEL A.V FISUTAL NEEDLE SET Exelint Intl. Co. FIE Class II 2001-12-07
K013880 DAYLITE XENON LIGHT SOURCES Designs For Vision, Inc. GCT Class II 2001-12-07
K013017 MEDIGROUP KEY TUBE Janin Group, Inc. FJS Class II 2001-12-06
K012988 HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469 Baxter Healthcare Corp FKX Class II 2001-12-05

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