meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
46
Latest Decision
2001-08-01

Clearances · page 49 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K012090 CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT Cordis, A Johnson & Johnson Co. FGE Class II 2001-08-01
K012066 PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY Sulzer Intratherapeutics, Inc. FGE Class II 2001-08-01
K012087 CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT Cordis Corp. FGE Class II 2001-08-01
DEN010002 GIVEN DIAGNOSTIC IMAGING SYSTEM Given Imaging , Ltd. NEZ Class II 2001-08-01
K010107 R STENT BILIARY ENDOPROSTHESIS Orbus Medical Technologies FGE Class II 2001-07-31
K003580 UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER Unisensor AG FFX Class II 2001-07-31
K011325 MEDIFIX URETEROSCOPE Medifix, Inc. FGB Class II 2001-07-25
K003949 TACKER, MODEL R65-933 A & A Medical, Inc. OCW Class II 2001-07-25
K010006 DRAINAGE CATHETER OR FOLEY CATHETER Applied Medical Resources Corp. EZL Class II 2001-07-25
K011281 INTUITIVE SURGICAL ULTRASONIC SHEARS Intuitive Surgical, Inc. NAY Class II 2001-07-24
K010400 VACUUM ASSISTED CORE BIOPSY DEVICE Promex, Inc. KNW Class II 2001-07-24
K011360 MTP LAPAROMAT DISPOSABLE TUBING SET Mtp Medical Technical Promotion GmbH GCJ Class II 2001-07-19
K011501 ENDOPOUCH RETRIEVER Ethicon Endo-Surgery, Inc. GCJ Class II 2001-07-19
K011206 PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES Parallax Medical, Inc. KNW Class II 2001-07-18
K011881 DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM Guidant Corp. FGE Class II 2001-07-18
K011552 UROLOGICAL CATHETER Apogee Medical, Inc. GBM Class II 2001-07-18
K011264 MESH URETERAL STENT Applied Medical Resources Corp. FAD Class II 2001-07-17
K011189 VIADUCT MICROENDOSCOPE AND ACCESSORIES Acueity, Inc. GCJ Class II 2001-07-16
K011965 IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1 Boston Scientific Corp KOD Class II 2001-07-13
K011257 ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM) Ethicon Endo-Surgery, Inc. GCJ Class II 2001-07-13
K011862 DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT Denver Biomedical, Inc. KPM Class II 2001-07-12
K011825 RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE Sightline Technologies , Ltd. FER Class II 2001-07-11
K011997 MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX Pajunk GmbH GCJ Class II 2001-07-10
K002838 GASTRIC SUCTION AND DRAINAGE CATHETER Bioenterics Corp. KNT Class II 2001-07-09
K011787 PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE Vidamed, Inc. KNS Class II 2001-07-06
K011359 MODIFICATION TO KSEA ENDOTIP SYSTEM KARL STORZ Endoscopy-America, Inc. GCJ Class II 2001-06-28
K011075 EASYBELL Biopsybell S.A.S. FCG Class II 2001-06-27
K003877 MAR COR SERVICES SEMPER PURE RO MACHINE Mar Cor Services, Inc. FIP Class II 2001-06-22
K011015 CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 C.R. Bard, Inc. NFK Class II 2001-06-22
K011435 HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM Hmt, Inc. KPI Class II 2001-06-22
K011018 TAUT BALLOON CATHETER, MODEL 50640 Taut, Inc. GCA Class II 2001-06-22
K011270 AUTOMATED CORE BIOPSY DEVICE Promex, Inc. FCG Class II 2001-06-22
K011773 DORNIER LITHOTRIPTER 140(DOLI 140) Dornier LNS Class II 2001-06-22
K002427 SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026 Sandhill Scientific, Inc. FFX Class II 2001-06-22
K011576 MEDCOMP ASH SPLIT Medical Components, Inc. NFK Class II 2001-06-21
K010870 LAP DISC 120 X 120, MODEL LD111, LAP DISC 120 X 100, MODEL LD112, LAP DISC 70 X 70, MODEL LD113 Ethicon Endo-Surgery, Inc. GCJ Class II 2001-06-18
K011183 OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE Advanced Surgical Concepts (Asc) GCJ Class II 2001-06-15
K011506 OMNILINK .035 BILIARY STENT SYSTEM Guidant Corp. FGE Class II 2001-06-15
K011148 ULTRACONCENTRATOR SYSTEM Interpore Cross Intl. FJI Class II 2001-06-13
K003207 MEDCOMP ULTRA-FLOW CATHETER Medical Components, Inc. MSD Class II 2001-06-12
K010760 ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS Advanced Renal Technologies, Inc. KPO Class II 2001-06-11
K003560 MAR COR SERVICES BICARB SYSTEM Mar Cor Services, Inc. FIN Class II 2001-06-08
K011055 THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS Go Medical Industries Pty. , Ltd. FCM Class II 2001-06-06
K010667 GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R Gambro Renal Products KDI Class II 2001-06-04
K010122 CONTINUOUS FLOW Y-TUBING G.U.-Tek LJH Class II 2001-06-04
K011020 DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER Denver Biomedicals, Inc. KPM Class II 2001-06-01
K003871 LAPAROSCOPIC HAND PORT Applied Medical Resources Corp. GCJ Class II 2001-05-31
K011104 OSTEOBELL Biopsybell S.A.S. KNW Class II 2001-05-31
K011002 INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000 Intuitive Surgical, Inc. NAY Class II 2001-05-30
K001971 HEMODIALYSIS TUBING SETS Ofi Biomedica S.P.A. FIB Class II 2001-05-24
K010620 ENDOSCOPIC STAPLE REMOVAL INSTRUMENT Onux Medical, Inc. GCJ Class II 2001-05-17
K003712 MODIFICATION TO MALE TO MALE LUER ADAPTER Molded Products, Inc. KOC Class II 2001-05-16
K010448 HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES Horizons Intl. Corp. FBK Class II 2001-05-16
K011151 EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z The Olympus Optical Co. FDS Class II 2001-05-15
K011149 DISPOSABLE BENDING CANNULA PR-233Q The Olympus Optical Co. ODD Class II 2001-05-15
K010519 MAGNUM FLOW IRRIGATION SYSTEM Scion Valley, Inc. GCJ Class II 2001-05-14
K010420 RUSCH MMG/O'NEIL CATHETER Rusch, Inc. FCM Class II 2001-05-09
K011077 ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22) Andersen Products, Inc. KNT Class II 2001-05-09
K011065 INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO) Richard Wolf Medical Instruments Corp. FFK Class II 2001-05-09
K011039 OMNILINK .018 BILIARY STENT SYSTEM Guidant Corp. FGE Class II 2001-05-08
K002801 MPS M ELECTRODE Medical Physics and Services, Inc. LNS Class II 2001-05-04
K011178 WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR Wilson-Cook Medical, Inc. LQC Class II 2001-05-04
K003123 RENAX A.V. FISTULA NEEDLE SETS Sunder Biomedical Tech. Co., Ltd. FIE Class II 2001-05-04
K003528 SANARUS CORE TISSUE BIOPSY SYSTEM Endocare, Inc. KNW Class II 2001-05-03
K010346 KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR KARL STORZ Endoscopy-America, Inc. GCJ Class II 2001-05-02
K003023 COBE HC 700 MIDI HEMOCONCENTRATOR Hospal Industrie KDI Class II 2001-04-30
K010993 ALIEN RX MICRO CANNULA, MODEL 4530 Boston Scientific Corp ODD Class II 2001-04-30
K010365 ORTHO CONTROL FEMALE URINARY CONTROL DEVICE Personal Products Co. MNG Class I 2001-04-30
K010264 NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET Nipro Medical Corp. FIB Class II 2001-04-27
K010268 FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9 Fresenius Medical Care North America KOC Class II 2001-04-27
K010789 CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1 A & A Medical, Inc. GCJ Class II 2001-04-27
K003325 KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM Karl Storz Imaging, Inc. FET Class II 2001-04-27
K011016 LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT Lsi Solutions GCJ Class II 2001-04-27
K010740 FG-36UX, FIBER ULTRASOUND GASTROSCOPE Pentax Precision Instrument Corp. ODG Class II 2001-04-17
K002929 DORNIER COMPACT ALPHA LITHOTRIPTER Dornier Medtech America, Inc. LNS Class II 2001-04-17
K010778 NIAGARA SLIM-CATH C.R. Bard, Inc. MPB Class II 2001-04-13
K010684 RX HERCULINK PLUS BILIARY STENT SYSTEM Guidant Corp. FGE Class II 2001-04-12
K010489 DYONICS VISION 111 MOBILE VIDEO UNIT Smith & Nephew, Inc. GCJ Class II 2001-04-10
K010779 MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT Gibbons Surgical Corp. FHO Class II 2001-04-10
K002902 TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS The Kendall Company MSD Class II 2001-04-09
K010569 KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP Karl Storz Endoscopy GCJ Class II 2001-04-09
K010220 XTRACTOR, MODEL M143 Instruments Medicaux G.B., Inc. GCJ Class II 2001-04-09
K010900 STS-T LITHOTRIPTER, MODEL STS-T Medstone Intl., Inc. LNS Class II 2001-04-05
K002892 FRSENIUS PD IQCARD CYCLER Fresenius Medical Care North America FKX Class II 2001-04-05
K010412 FLEXIBLE ENDOSCOPIC SCISSORS Telemed Systems, Inc. OCZ Class II 2001-04-02
K004040 REDTECH GIPC 2000 Red-Tech, Inc. FFX Class II 2001-03-29
K003873 MENTOR SELF-CATH CLOSED SYSTEM Mentor Corp. FCM Class II 2001-03-29
K010567 OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR C.R. Bard, Inc. MSD Class II 2001-03-28
K002901 KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER The Kendall Company MSD Class II 2001-03-28
K003113 KSEA SCB-RUI SCO KARL STORZ Endoscopy-America, Inc. FET Class II 2001-03-27
K010568 ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM Arthrocare Corp. KNS Class II 2001-03-27
K010610 RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527 Boston Scientific Corp ODC Class II 2001-03-27
K000724 MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300 Medica S.R.L. KDI Class II 2001-03-22
K003929 NIROYAL BILIARY PREMOUNTED STENT SYSTEM Boston Scientific Corp FGE Class II 2001-03-22
K002154 K.E.A.T. Emd Electronic Medical Devices, Corp. KPI Class II 2001-03-22
K010037 DAUM DOUBLE-SHOOT BISOPSY GUN Daum GmbH KNW Class II 2001-03-22
K010445 PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM Cordis Corp. FGE Class II 2001-03-16
K010591 OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER Olympus Optical Co., Ltd. ODG Class II 2001-03-15
K000881 PERFADEX SOLUTION FOR ORGAN PRESERVATION Vitrolife Sweden AB MSB Class II 2001-03-08
K010339 ENDOCARE PERCUTANEOUS ACCESS SET Endocare, Inc. KOD Class II 2001-03-07

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