meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
49
Latest Decision
2001-03-07

Clearances · page 50 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K003803 GENERAL SURGICAL LAPAROSCOPES Global Endoscopy, Inc. GCJ Class II 2001-03-07
K003784 MENTOR SELF-CATH PLUS Mentor Corp. EZL Class II 2001-03-05
K002489 INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM Intuitive Surgical, Inc. NAY Class II 2001-03-02
K003102 PARE ENDOSCOPIC SUTURING SYSTEM Pare Surgical, Inc. OCW Class II 2001-02-27
K001744 OLYMPUS ENDOSCOPIC LIGATION DEVICE Olympus America, Inc. MND Class II 2001-02-27
K010007 ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP Taut, Inc. GCJ Class II 2001-02-22
K003806 URETEROSCOPES Global Endoscopy, Inc. FGB Class II 2001-02-22
K003807 CYSTOSCOPES Global Endoscopy, Inc. FAJ Class II 2001-02-22
K002045 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS Total Water Treatment Systems, Inc. FIP Class II 2001-02-16
K001916 COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX Novartis Nutrition Corp. KNT Class II 2001-02-16
DEN000008 DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) Life Technologies, Inc. NDS Class II 2001-02-16
K002650 VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726 Bentec Medical, Inc. FGE Class II 2001-02-16
K002210 SYNTRA DIALYZER, MODEL SYNTRA 120, 160 Baxter Healthcare Corp KDI Class II 2001-02-14
K010340 MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI Karl Storz Lithotripsy-America, Inc. LNS Class II 2001-02-13
K002583 TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM Vidamed, Inc. KNS Class II 2001-02-13
K003529 SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS Edap Technomed, Inc. LNS Class II 2001-02-12
K010130 POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103 Medtronic Functional Diagnostics A/S FFX Class II 2001-02-07
K003710 DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONICS AUTOCLAVABLE CAMERA COUPLER MODEL 7207905 Smith & Nephew, Inc. FET Class II 2001-02-02
K003443 SUCTION IRRIGATOR Applied Medical FHF Class II 2001-02-01
K010098 MODIFICATION TO CAVERMAP SURGICAL AID Uromed Corp. FGM Class I 2001-02-01
K003425 CLIRANS E-SERIES HOLLOW FIBER DIALYZERS Terumo Medical Corp. KDI Class II 2001-02-01
K003615 STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS Environmental Test Systems, Inc. FKP Class II 2001-02-01
K002231 LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY EQUIPMENT Olympus Optical Co., Ltd. FDS Class II 2001-01-30
K003997 INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS Intratherapeutics, Inc. FGE Class II 2001-01-24
K002235 HORIZONS ERCP CANNULA Horizons Intl. Corp. FGE Class II 2001-01-23
K002236 HORIZONS PAPILLOTOME Horizons Intl. Corp. KNS Class II 2001-01-23
K002011 GLUTARTEST 1 REAGENT STRIP Integrated Biomedical Technology, Inc. MSY Class II 2001-01-22
K010002 CONTOUR POLARIS URETERAL STENT Boston Scientific Corp FAD Class II 2001-01-22
K003297 MAMMOTOME HAND HELD PROBE, MODEL MHH8 Ethicon Endo-Surgery, Inc. KNW Class II 2001-01-18
K001283 LIFEMATE HEMOFILTRATION SYSTEM Nxstage Medical, Inc. KDI Class II 2001-01-17
K001859 PENILE CONSTRICTOR RING Basic Solutions, LLC LKY Class II 2001-01-11
K003186 BARD MEMOTHERM ENDOSCOPIC BILIARY STENT C.R. Bard, Inc. FGE Class II 2001-01-09
K003793 BARD LUMINEXX BILIARY STENT C.R. Bard, Inc. FGE Class II 2001-01-05
K003956 BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595 C.R. Bard, Inc. ODE Class II 2001-01-05
K003289 BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED); BARDEX LUBRI-SIL TEMPERATURE-SENSING FOLEY CATHETER (LU C.R. Bard, Inc. EZL Class II 2001-01-05
K003753 GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE Uresil Corp. FGE Class II 2001-01-04
K003498 FRESENIUS OPTIFLUX 200A Fresenius Medical Care North America KDI Class II 2001-01-04
K994292 WATER PURIFICATION SYSTEM Water & Power Technologies, Inc. FIP Class II 2001-01-02
K003451 DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T Denver Biomedicals, Inc. KPM Class II 2001-01-02
K003040 INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY Intratherapeutics, Inc. FGE Class II 2000-12-28
K002803 THE O'NEIL STERILE FIELD URINARY CATHETER KIT Go Medical Industries Pty. , Ltd. FCM Class II 2000-12-27
K994279 PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION) Pure Water Solutions, Inc. FIP Class II 2000-12-22
K003790 DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005 Davol, Inc. GCJ Class II 2000-12-22
K001763 CRIT-LINE MONITOR III (CLM III) In-Line Diagnostics Corp. MQS Class II 2000-12-20
K003115 ACTIS ADJUSTABLE CONSTRICTION LOOP Vivus, Inc. LKY Class II 2000-12-19
K002944 PRECISA BIOPSY NEEDLE H.S. Hospital Service S.R.L. FCG Class II 2000-12-19
K002946 SILENT BIOPSY NEEDLE H.S. Hospital Service S.R.L. FCG Class II 2000-12-19
K003569 PLASMAKINETIC ENDOUROLOGY SYSTEM Gyrus Medical , Ltd. KNS Class II 2000-12-19
K002947 BIOMOL ASPIRATION BIOPSY NEEDLE H.S. Hospital Service S.R.L. FCG Class II 2000-12-19
K003439 VIVANT BREAST LESION LOCALIZATION DEVICE Vivant Medical, Inc. KNW Class II 2000-12-15
K001282 AIW WATER SYSTEM FOR HEMODIALYSIS American Industrial Water FIP Class II 2000-12-15
K000249 SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100 Schaefer Water Centers FIP Class II 2000-12-11
K003078 MERIT DRAINAGE DEPOT Merit Medical Systems, Inc. EXF Class II 2000-12-11
K002927 SNARE,FLEXIBLE Odon Lifetechnology FDI Class II 2000-12-10
K002868 BARD ALL-SILICONE 3-WAY FOLEY CATHETER; BARD LUBRI-SIL 3-WAY FOLEY CATHETER; BARD LUBRI-SIL I.C. 3-WAY FOLEY CATHETER C.R. Bard, Inc. EZL Class II 2000-12-08
K003450 INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS Intratherapeutics, Inc. FGE Class II 2000-12-07
K001465 NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET Nipro Medical Corp. FIB Class II 2000-12-05
K002761 FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS Fresenius Medical Care North America FJI Class II 2000-12-04
K002749 ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D The Olympus Optical Co. FDF Class II 2000-12-04
K003445 FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2 Fresenius Medical Care North America FIB Class II 2000-12-01
K003336 MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. FGE Class II 2000-11-22
K001563 SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET Scion Cardiovascular, Inc. FGO Class II 2000-11-22
K003365 S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS) Cordis Corp. FGE Class II 2000-11-22
K002816 TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV Transonic Systems, Inc. KOC Class II 2000-11-22
K002778 ENTERIC INJECTION CATHETER WITH IRRIGATION Enteric Medical Technologies, Inc. FBK Class II 2000-11-22
K003370 JAMSHIDI MARROW ACQUISITION CRADLE Allegiance Healthcare Corp. KNW Class II 2000-11-22
K002813 NIPRO SAFETOUCH SAFETY FISTULA NEEDLE Nipro Medical Corp. FIE Class II 2000-11-21
K002573 ADVANCED UROSCIENCE INNERSHEATH Advanced Uroscience, Inc. FBK Class II 2000-11-16
K001685 PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 Baxter Healthcare Corp MSE Class II 2000-11-15
K002398 ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING Ethicon Endo-Surgery, Inc. OCW Class II 2000-11-03
K003217 HERMES PORT EXPANDER Computer Motion, Inc. GCJ Class II 2000-11-03
K002924 3D ENDOSCOPE KARL STORZ Endoscopy-America, Inc. GCJ Class II 2000-11-03
K003222 MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER Computer Motion, Inc. GCI Class II 2000-11-03
K002363 MEDOVATIONS ESOPHAGEAL DILATOR Medovations, Inc. KNQ Class II 2000-11-01
K002546 CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE CIVCO Medical Instruments Co., Inc. KNW Class II 2000-10-31
K001408 KSEA VASCULAR FIBERSCOPES KARL STORZ Endoscopy-America, Inc. LYK Class II 2000-10-30
K002130 NIR BILIARY STENT Medinol, Ltd. FGE Class II 2000-10-30
K994390 GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER Gambro Healthcare MSF Class II 2000-10-26
K002372 ACCESS ALERT GAUGE Medisystems Corp. KOC Class II 2000-10-25
K001811 NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM Neu-Ion, Inc. FIP Class II 2000-10-25
K002431 ELRAN 01 SYSTEM Envision Advanced Medical System, Ltd. GCJ Class II 2000-10-24
K002542 REUSABLE CANNULA Genicon, LC GCJ Class II 2000-10-23
K000730 IMPOAID Impoaid, Inc. LKY Class II 2000-10-19
K000252 INSIGHT 4000 ENDOSCOPE Insight Instruments Mfg., Inc. MPA Class II 2000-10-17
K002396 ENDOCARE PERCUTANEOUS ACCESS SET Endocare, Inc. KOD Class II 2000-10-13
K002143 DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM Guidant Corp. FGE Class II 2000-10-12
K002133 NIR BILLIARY STENT SYSTEM; MARSHAL BALLOON DILATATION CATHETER Boston Scientific Corp FGE Class II 2000-10-12
K002802 RAPID EXCHANGE TAPERTOME Boston Scientific Corp KNS Class II 2000-10-05
K002028 BRAVO PH MONITORING SYSTEM Endonetics, Inc. FFT Class I 2000-09-29
K002013 OMNIPORT Advanced Surgical Concepts (Asc) GCJ Class II 2000-09-29
K001958 KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL 12 F DUO-FLOW AND 14F DUO-FLOW 400 XL CATH Keystone Medical MPB Class II 2000-09-25
K993933 14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO Arrow Intl., Inc. MPB Class II 2000-09-14
K001766 OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE Olympus Optical Co., Ltd. FDS Class II 2000-09-08
K000251 SPECTRUM SILICONE FOLEY CATHETER Cook Urological, Inc. MJC Class II 2000-08-30
K001338 MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER Boston Scientific Corp FGE Class II 2000-08-30
K001903 NEOCONTROL PELVIC FLOOR THERAPY SYSTEM Neotonus, Inc. KPI Class II 2000-08-29
K991495 FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS Fluid Process Systems, Inc. FIP Class II 2000-08-28
K001648 INTRASTENT DOUBLESTRUT PARAMOUNT Intratherapeutics, Inc. FGE Class II 2000-08-28
K994198 HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L Toray Industries (America), Inc. KDI Class II 2000-08-25
K002277 FRESENIUS OPTIFLUX 200NR Fresenius Medical Care North America KDI Class II 2000-08-25

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