meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
44
Latest Decision
2008-06-17

Clearances · page 36 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K081057 INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL Intact Medical Corporation KNW Class II 2008-06-17
K073598 BARD DIGNICARE STOOL MANAGEMENT SYSTEM C.R. Bard, Inc. KNT Class II 2008-06-13
K080519 PRISMAFLEX M150 SET Gambro Renal Products, Inc. KDI Class II 2008-06-13
K073288 ETHICON ENDO SURGERY ARTICULATING SNARE Ethicon Endo-Surgery, Inc. FDI Class II 2008-06-12
K080881 CURE CATHETER CLOSED SYSTEM Cure Medical, LLC KOD Class II 2008-06-11
K080550 MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 Minos Medical ODB Class II 2008-06-10
K080703 BTI FILTRATION DEIONIZATION EXCHANGE TANK; BTI FILTRATION CARBON EXCHANGE TANK 4m Ventures, Inc. FIP Class II 2008-06-02
K063532 BARD E LUMINEXX BILIARY STENT Bard Peripheral Vascular, Inc. FGE Class II 2008-05-30
K080161 PASPORT OPTICAL TROCAR, VORTEX SEAL, BLUNT TIP TROCAR, SHIELDED TROCAR, CANNULA ANCHOR Patton Surgical Corp. GCJ Class II 2008-05-29
K081169 AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR Covidien Lp, Formerly Registered AS United States GCJ Class II 2008-05-23
K080257 MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS Medtronic Xomed, Inc. GCJ Class II 2008-05-22
K080946 CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX Conmed Endoscopic Technologies, Inc. KNS Class II 2008-05-20
K080403 XTJF TYPE Q160VF1 Olympus Medical Systems Corporation FDT Class II 2008-05-20
K081142 AUTO-BAND LIGATOR Scandimed International MND Class II 2008-05-16
K080977 3 CCD ENDOCAM 5550 Richard Wolf Medical Instruments Corp. GCJ Class II 2008-05-14
K072749 SIALO BALLOON DILATATION CATHETER Sialo Technology, Ltd. GCJ Class II 2008-05-14
K080328 MPS ACACIA ENTERAL FEEDING TUBE Mps Acacia KNT Class II 2008-05-14
K080400 ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT AngioDynamics, Inc. MSD Class II 2008-05-13
K080007 GRADUATED ADAPTER WITH CLAVE Icu Medical, Inc. EZD Class II 2008-05-13
K080654 PAJUNK'S KIT FOR BALLOON AIDED LAPAROSCOPY PAJUNK GmbH Medizintechnologie GCJ Class II 2008-05-08
K080764 SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100 Max Endoscopy, Inc. ODC Class II 2008-05-06
K080586 OLYMPUS XCHF TYPE B180Y1 Olympus Medical Systems Corporation FBN Class II 2008-05-06
K080050 SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE Spirus Medical, Inc. FED Class II 2008-05-06
K080712 SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 Serim Research Corp. MSY Class II 2008-05-06
K081004 PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL Stryker GI FDF Class II 2008-05-02
K080317 ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT ,MODEL PEL Syntheon, LLC FDF Class II 2008-04-29
K072613 DIRECTVIEW, LIGHTGUIDE, MODEL(S) 10RLL-320 LAPAROSCOPE, 10DLG-320 DISPOSABLE LIGHT GUIDE FOR ABOVE Micro Invasive Technology, Inc. GCJ Class II 2008-04-21
K072811 MARIONETTE SA, MODEL 001 001 & 001 002 Kinetic Surgical, LLC GCJ Class II 2008-04-21
K080095 CORAMATE/SPIROTOME SYSTEM Medinvents KNW Class II 2008-04-11
K072720 ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM Alveolus, Inc. FGE Class II 2008-04-11
K080132 THD DISPOSABLE ANOSCOPE/PROCTOSCOPE Thd Spa FER Class II 2008-04-09
K080410 KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522 KARL STORZ Endoscopy-America, Inc. ODA Class II 2008-04-09
K073671 PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE Ndo Surgical, Inc. OCW Class II 2008-03-26
K071254 SMALL INTESTINAL VIDEOSCOPE SYSTEM Olympus Medical Systems Corporation FDA Class II 2008-03-25
K080051 VIRTUAL PORTS ENDOCLEAR SYSTEM Virtual Ports, Ltd. GCJ Class II 2008-03-21
K080508 MANDREL GUIDEWIRES OR M-WIRE Lake Region Medical OCY Class II 2008-03-21
K080291 INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER Intuitive Surgical, Inc. NAY Class II 2008-03-19
K073718 MEDLINE GASTROSTOMY TUBE Medline Industries, Inc. KGC Class II 2008-03-19
K072301 5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05 Ev3, Inc. FGE Class II 2008-03-18
K072957 EVIS EXERA II 180 SYSTEM Olympus Medical Systems Corporation NWB Class II 2008-03-18
K073034 AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419) Applied Medical Technology, Inc. KNT Class II 2008-03-14
K073484 ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432 Ethicon Endo-Surgery, Inc. ODC Class II 2008-03-10
K080171 SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012 Sanarus Medical, Inc. KNW Class II 2008-03-06
K080155 MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM Intuitive Surgical, Inc. GCJ Class II 2008-03-06
K073552 LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY Laborie Medical Technologies, Corp. FEN Class II 2008-03-05
K073507 ANCHORAGE ACCESS KIT Epitek, Inc. ODC Class II 2008-03-05
K073279 VS-VISIONSENSE STEREOSCOPIC VISION SYSTEM Visionsense, Ltd. GCJ Class II 2008-03-05
K080340 COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG Novartis Nutrition Corp. KNT Class II 2008-03-05
K080253 KIMBERLY-CLARK INTRODUCER KITS Kimberly-Clark Corp. KGC Class II 2008-02-26
K072988 NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 Nipro Medical Corporation FIB Class II 2008-02-21
K072158 AQUA PURE DEIONIZER EXCHANGE SERVICE Staubach Barror Water Systems, Inc. FIP Class II 2008-02-21
K070947 INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPER Intuitive Surgical, Inc. NAY Class II 2008-02-14
K072627 INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST INTRODUCER Intuitive Surgical, Inc. NAY Class II 2008-02-07
K062798 SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB Cordis Corp. FGE Class II 2008-02-06
K072908 PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY Gambro Renal Products KPO Class II 2008-02-04
K072093 PRISMAFLEX SYSTEM, VERSION 3.20 Gambro KDI Class II 2008-02-01
K071646 SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120 Idev Technologies, Inc. FGE Class II 2008-01-31
K072538 PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER United Medical Systems, Inc. LNS Class II 2008-01-30
K072760 SOLCART B B. Braun Medizintechnologie GmbH KPO Class II 2008-01-29
K073719 ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE Advanced Surgical Concepts GCJ Class II 2008-01-29
K073092 DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40, Spire Biomedical, Inc. MSD Class II 2008-01-29
K073672 SKATER BILIARY CATHETER Angiotech FGE Class II 2008-01-24
K073093 DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36, Spire Biomedical, Inc. MSD Class II 2008-01-22
K072652 ENTERAL FEEDING SPIKE ADAPTER Cedic S.R.L. KNT Class II 2008-01-18
K071104 ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM Flier'S Quality Water Systems, Inc. FIP Class II 2008-01-14
K072881 NEOMED Enteral FEEDING TUBE Neomed, Inc. FPD Class II 2008-01-09
K072684 MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM Mondeal North America, Inc. OCZ Class II 2008-01-04
K070665 LITHOSKOP Siemens Medical Solutions USA, Inc. LNS Class II 2008-01-04
K072788 STORZ MODULITH LITHOTRIPTER SLX-F2-F180 KARL STORZ Endoscopy-America, Inc. LNS Class II 2007-12-26
K073399 TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE Envisioneering, LLC FCG Class II 2007-12-21
K072756 NON-IV ADAPTER FOR INFANT NG TUBE Promedic, Inc. KNT Class II 2007-12-19
K072997 NEOMED URINARY CATHETER Neomed, Inc. EZD Class II 2007-12-19
K070873 AMSURE BLADDER IRRIGATION SET Amsino Intl., Inc. LJH Class II 2007-12-19
K072180 VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM Vision-Sciences, Inc. FAJ Class II 2007-12-18
K072476 THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT Boston Scientific Corporation KNT Class II 2007-12-14
K072594 GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM Gyrus Acmi, Inc. FGA Class II 2007-12-13
K072550 SIGHTSURE OPERATIONAL INDICATOR, MODEL SS301 Medevice, Inc. KNT Class II 2007-12-07
K072354 GUIDEWIRE, MODEL G-V220-3527S AND OTHERS Accellent, Inc. OCY Class II 2007-12-07
K070558 BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS C.R. Bard, Inc. EZL Class II 2007-12-07
K070582 BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS C.R. Bard, Inc. EZL Class II 2007-12-07
K073009 ONEPORT SURGICAL TROCAR SYSTEM Conmed Corporation GCJ Class II 2007-12-07
K073170 R-PORT II LAPAROSCOPIC ACCESS DEVICE Advanced Surgical Concepts GCJ Class II 2007-12-03
K071202 DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS) Dermaport, Inc. MSD Class II 2007-11-30
K072383 HABIB ENDOBLATE Emcision , Ltd. KNS Class II 2007-11-29
K071579 PEF TUBE N.M. Beale Co., Inc. KNT Class II 2007-11-20
K072521 COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH Cook Urological, Inc. FFS Class II 2007-11-20
K072912 SOPRO 225 DUAL HALOGEN LIGHT SOURCE Sopro GCJ Class II 2007-11-16
K063733 RESOLVE BILIARY DRAINAGE CATHETER Merit Medical Systems, Inc. FGE Class II 2007-11-14
K072808 SPEEDICATH COMPACT Coloplast Corp. GBM Class II 2007-11-09
K062264 COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM Medtronic Vascular FGE Class II 2007-11-08
K070643 PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35 Gambro, Inc. KDI Class II 2007-11-02
K070799 MODULARIS VARIOSTAR Siemens Medical Solutions USA, Inc. LNS Class II 2007-11-01
K072787 GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111 Syncro Medical Innovations, Inc. KNT Class II 2007-10-31
K072499 NOVOFLO CATHETER LT Novosci, Inc. MSD Class II 2007-10-30
K071764 REALIZE GASTRIC CALIBRATION TUBE, MODELS GCT180, GCT360 Obtech Medical Sarl KNT Class II 2007-10-24
K072422 CYBERWAND STERILE PADS, MODEL: CW-RBPBX Cybersonics, Inc. FFK Class II 2007-10-24
K072045 ONCONTROL BONE MARROW BIOPSY SYSTEM Vidacare Corporation KNW Class II 2007-10-22
K072125 ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT Ndo Surgical, Inc. ODE Class II 2007-10-18
K071013 REDSENSE Redsense Medical AB ODX Class II 2007-10-18
K071909 PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R Barkey GmbH & Co. KG KOC Class II 2007-10-18

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