meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
51
Latest Decision
2002-10-21

Clearances · page 46 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K022391 MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION Organ Recovery Systems, Inc. KDN Class II 2002-10-21
K020231 DIASOL-ADDITIVES Diasol, Inc. KPO Class II 2002-10-21
K021856 PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX Porges S.A. EYB Class II 2002-10-17
K013921 PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X Porges S.A. FAD Class II 2002-10-17
K022595 WILSON-COOK CYSTOTOME Wilson-Cook Medical, Inc. KNS Class II 2002-10-17
K022620 SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT Spire Biomedical, Inc. FKA Class II 2002-10-11
K022897 MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER Computer Motion, Inc. GCJ Class II 2002-10-11
K022286 ENCIRCLE LOCALIZATION DEVICE Vivant Medical, Inc. KNW Class II 2002-10-11
K020936 10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL Medcomp MSD Class II 2002-10-11
K022826 CLEAR-IT ANTI-FOG, MODEL PS003 Preservation Solutions, Inc. OCT Class II 2002-10-09
K023053 DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM Smith & Nephew, Inc. GCJ Class II 2002-10-03
K021142 ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865 Fortune Medical Instrument Corp. EZL Class II 2002-10-01
K021266 ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018 Ethicon Endo-Surgery, Inc. KNS Class II 2002-09-27
K020542 DAYTRIPPER DIALYSATE WARMER Stickman Industries, Inc. MLW Class II 2002-09-27
K021152 ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES Computer Motion, Inc. NAY Class II 2002-09-24
K022879 MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY Sanarus Medical, Inc. KNW Class II 2002-09-23
K020848 NAFD 100 Neomatrix, LLC KNW Class II 2002-09-23
K022287 3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS 3t Medical Systems, LLC EZL Class II 2002-09-23
K022068 TUBING, DIALYSATE (AND CONNECTOR) Molded Products, Inc. FID Class II 2002-09-23
K020255 RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590 Richard Wolf Medical Instruments Corp. ODA Class II 2002-09-18
K022135 URETERAL ACCESS SHEATH SET (UASS) Boston Scientific Corp KOD Class II 2002-09-13
K021276 FG-36UX FIBER ULTRASOUND GASTROSCOPE Pentax Precision Instrument Corp. ODG Class II 2002-09-12
K021278 EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE Pentax Precision Instrument Corp. ODG Class II 2002-09-06
K022229 SMARTSTITCH SUTURE DEVICE, MODEL OM-8500 Opus Medical, Inc. OCW Class II 2002-09-06
K022648 ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521 Boston Scientific Corp KNT Class II 2002-09-05
K002612 BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON C.R. Bard, Inc. EZL Class II 2002-09-03
K021847 BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES Biopsy Sciences, LLC FCG Class II 2002-09-03
K021493 ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S Andersen Products, Inc. KNT Class II 2002-08-30
K022543 ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM Arthrocare Corp. FAS Class II 2002-08-30
K021759 14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55 Medcomp MSD Class II 2002-08-27
K022561 CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 C.R. Bard, Inc. NFK Class II 2002-08-23
K013051 NANMA ADJUSTABLE CONSTRICTION RING Nanma Mfg Co., Ltd. LKY Class II 2002-08-22
K021717 ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5 World of Medicine Lemke GmbH GCT Class II 2002-08-20
K011700 MODULITH SLK LITHOTRIPTER Karl Storz Endoscopy LNS Class II 2002-08-16
K021747 DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR Surgicon, Inc. GCI Class II 2002-08-15
K021776 KSEA QUADRO SWITCH Karl Storz Endoscopy OCX Class II 2002-08-15
K021898 SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. FGE Class II 2002-08-14
K022270 MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA Olympus Optical Co., Ltd. ODA Class II 2002-08-14
K021707 SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS Senorx, Inc. KNW Class II 2002-08-14
K021571 TRANSONIC FLOW-QC SET MODEL ADT1010 Transonic Systems, Inc. MQS Class II 2002-08-12
K022362 GIVEN DIAGNOSTICS SYSTEM Given Imaging , Ltd. NEZ Class II 2002-08-09
K013784 URETERAL STENT Boston Scientific Corp FAD Class II 2002-08-08
K021731 ADAPT OPEN ACCESS PORT, MODEL 41233 Taut, Inc. GCJ Class II 2002-08-08
K010805 PRISMA SYSTEM Gambro Renal Products KDI Class II 2002-08-06
K022434 BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U C.R. Bard, Inc. MND Class II 2002-08-05
K001755 MPW HEMODIALYSIS WATER PURIFICATION SYSTEM Mpw Industrial Water Services, Inc. FIP Class II 2002-08-05
K013704 MEDIPLUS SINGLE USE GI MANOMETRY CATHETER Mediplus , Ltd. KLA Class II 2002-08-05
K020120 ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220 Boston Scientific Corp KNT Class II 2002-08-02
K021352 DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS Dayton Water Systems FIP Class II 2002-08-01
K021456 ER150/M2 World of Medicine Lemke GmbH GCJ Class II 2002-08-01
K012644 REPROCESSED TROCARS AND CANNULAS Surgical Instruments Service and Savings, Inc. NLM Class II 2002-07-29
K021602 FOSSA URETERAL STONE SWEEPER Fossa Industries, Inc. FAD Class II 2002-07-26
K022169 CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES Parallax Medical, Inc. KNW Class II 2002-07-25
K020103 PRISMAFLO Stihler Electronic GmbH KOC Class II 2002-07-24
K011741 CRIT-LINE MONITOR III TQA (CLM TQA) Hemametrics FIL Class II 2002-07-23
K022000 POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES) Spire Biomedical, Inc. MSD Class II 2002-07-19
K022026 MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS) Medtronic Ave, Inc. FGE Class II 2002-07-19
K021991 MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE Syncro Medical Innovations, Inc. KNT Class II 2002-07-18
K020005 INFANT FEEDING TUBES Promedic, Inc. KNT Class II 2002-07-16
K013713 ARM AUTOMATIC REPROCESSING MACHINE Alcavis International Incorporated LIF Class II 2002-07-15
K021998 HORIZONS CYTOLOGY BRUSH Horizons Intl. Corp. FDX Class II 2002-07-12
K021525 TOPCUT H.S. Hospital Service S.R.L. FCG Class II 2002-07-12
K013418 AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY Asahi Medical Co., Ltd. KDI Class II 2002-07-09
K013634 BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK Bioteque Corp. FJK Class II 2002-07-09
K014297 ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT; ENDOVIVE LOW PROFILE BUTTON REPLACEMENT GASTROSTOMY TUBE; SECURI-T INITIAL P Boston Scientific Corp KNT Class II 2002-07-09
K021179 DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A Olympus Optical Co., Ltd. OCY Class II 2002-07-05
K021824 DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010 Guidant Corp. FGE Class II 2002-07-02
K020714 RUSCH FLONEIL; FLOCATH INTROGEL Rusch Intl. GBM Class II 2002-07-01
K021140 FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT Fossa Industries, Inc. FAD Class II 2002-06-28
K021345 MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM Cordis Corp. FGE Class II 2002-06-28
K021290 VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE ACTIVATION AND PIP, MODEL 9100 Vista Medical Technologies, Inc. GCJ Class II 2002-06-28
K003720 ANGEL OF WATER COLON HYDROTHERAPY SYSTEM Lifestream Purfication Systems, LLC KPL Class II 2002-06-27
K021034 MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER Tfx Medical, Inc. KNT Class II 2002-06-26
K021036 INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000 Intuitive Surgical, Inc. NAY Class II 2002-06-26
K021137 SANARUS CENTRICA CORE TISSUE BIOPSY SYSTEM Sanarus Medical, Inc. KNW Class II 2002-06-26
K020987 BMN I TYPE MARROW ASPIRATION NEEDLE H.S. Hospital Service S.R.L. KNW Class II 2002-06-25
K020985 MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER Tfx Medical, Inc. KNT Class II 2002-06-25
K021729 MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY Sulzer Intratherapeutics, Inc. FGE Class II 2002-06-21
K021706 HORIZONS HOT BIOPSY FORCEPS Horizons Intl. Corp. KGE Class II 2002-06-21
K021886 OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P Olympus Optical Co., Ltd. FDS Class II 2002-06-19
K020891 NAKAO SNARE II AND NAKAO SNARE III Granit Medical Innovations FDI Class II 2002-06-17
K020915 SOPRO LIGHT SOURCES AND ACCESSORIES Sopro GCJ Class II 2002-06-14
K012232 INSIGHT, MODEL S980000 Sandhill Scientific, Inc. FFX Class II 2002-06-07
K020969 VACURECT VACUUM CONSTRICTION DEVICE Vacurect Manufacturing (Pty) , Ltd. LKY Class II 2002-06-05
K020889 ENDOSCOPIC LIGHT SOURCE XL202/L3 World of Medicine Lemke GmbH GCT Class II 2002-06-05
K013733 SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET Chf Solutions, Inc. KDI Class II 2002-06-03
K013712 ENTERYX INJECTOR Enteric Medical Technologies FBK Class II 2002-05-31
K020614 IRRIGATING CANNULA Ca Guard, Ltd. OCX Class II 2002-05-24
K020315 14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL Medcomp MSD Class II 2002-05-24
K020577 APPLIED URETERAL CATHETER Applied Medical Resources Corp. EYB Class II 2002-05-22
K020465 MEDCOMP ASH SPLIT-CATH II Medcomp MSD Class II 2002-05-22
K020908 HDM97 Ibp Instruments GmbH FIZ Class II 2002-05-22
K020909 HDM99 Ibp Instruments GmbH FIZ Class II 2002-05-22
K020867 BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL Worldwide Medical Technologies, LLC KNW Class II 2002-05-20
K021212 24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS Spire Biomedical, Inc. MSD Class II 2002-05-17
K013053 MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING Nanma Mfg Co., Ltd. LKY Class II 2002-05-09
K020430 DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) Diatek, Inc. NFK Class II 2002-05-09
K021166 ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR Acmi-Circon Corporation FDC Class II 2002-05-09
K020788 WILSON-COOK ZILVER BILIARY STENT Wilson-Cook Medical, Inc. FGE Class II 2002-05-08
K012716 MAINSTREAM WATER PURIFICATION DEVICE Prismedical Corp. NHV Class II 2002-05-07

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