meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
50
Latest Decision
2007-02-22

Clearances · page 38 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K070266 560 HIGH DEFINITION CAMERA SYSTEM Smith & Nephew, Inc. GCJ Class II 2007-02-22
K062444 HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT Oasis Medikal Urunler Kimya Sanayi VE Tic A.S. EZD Class II 2007-02-22
K070102 SOPRO 162 CAMERA Sopro GCJ Class II 2007-02-20
K063183 PRISMA M10 PRE SET Gambro Renal Products, Inc. KDI Class II 2007-02-15
K063697 SPECIAL SPROTTE, CHIBA, DR STEINHOFF KIT PAJUNK GmbH Medizintechnologie KNW Class II 2007-02-14
K063118 BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE C.R. Bard, Inc. KNT Class II 2007-02-13
K063441 15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55 Spire Biomedical, Inc. MSD Class II 2007-02-12
K062953 MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE Medisystems Corp. FIE Class II 2007-02-12
K063700 SPYGLASS IRRIGATION SYSTEM Medical Scientific, Inc. LJH Class II 2007-02-08
K062901 HEMOCATH II Med-Conduit, Inc. MSD Class II 2007-02-08
K063368 NIPRO BIOHOLE NEEDLE Nipro Medical Corp. FIE Class II 2007-02-05
K062497 REPROCESSED TROCARS Ascent Healthcare Solutions NLM Class II 2007-01-31
K063654 ENDOGUIDE Kms Medical, LLC FDF Class II 2007-01-31
K070129 SONOTIP II ULTRASOUND NEEDLE SYSTEM Medi-Globe Corporation FCG Class II 2007-01-31
K063585 KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM KARL STORZ Endoscopy-America, Inc. FDF Class II 2007-01-31
K063290 GAMBRO QUICKSET BLOODLINES Gambro Renal Products FJK Class II 2007-01-30
K063431 15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40 Spire Biomedical, Inc. MSD Class II 2007-01-29
K062918 KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM KARL STORZ Endoscopy-America, Inc. FBO Class II 2007-01-17
K063528 TROCASYS PAJUNK GmbH Medizintechnologie GCJ Class II 2007-01-17
K063309 TRU-CABLE Truphatek International, Ltd. FFS Class II 2007-01-12
K063721 NIPRO SAFETOUCH II GAMMA Nipro Medical Corp. FIE Class II 2007-01-12
K061430 SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR Custom Ultrasonics FEB Class II 2007-01-12
K063587 XODUS MEDICAL ANTI-FOG SOLUTION Xodus Medical, Inc. OCT Class II 2007-01-09
K063677 FUSION QUATTRO EXTRACTION BALLOON XL Wilson-Cook Medical, Inc. GCA Class II 2007-01-05
K061782 GAMBRO POSICLEAR Gambro Services, Inc. FIP Class II 2007-01-04
K062968 LAPMAN LAPAROSCOPE MANIPULATOR AND ACCESSORIES, MODEL 900-200 SERIES Medsys, S.A. GCJ Class II 2007-01-03
K062517 ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES Olympus Medical Systems Corporation KGE Class II 2006-12-22
K061350 LITHODIAMOND ULTRA Pck Electronic Industry & Trade Co., Ltd. LNS Class II 2006-12-22
K063446 CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 C.R. Bard, Inc. NFK Class II 2006-12-15
K062551 NEXUS IRRIGATION TUBING SET Nexus Medical, LLC LJH Class II 2006-12-15
K062922 MODIFICATION TO AQUADEX FLEXFLOW SYSTEM Chf Solutions, Inc. KDI Class II 2006-12-13
K052298 CYSTOGLIDE INTRODUCER SHEATH Percutaneous Systems, Incorporated KNY Class II 2006-12-12
K062707 RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE Innovative Endoscopy Components, LLC FGB Class II 2006-12-08
K063457 TRUEHD (1080P) DIGITAL CAMERA SYSTEM Conmed Linvatec GCJ Class II 2006-12-05
K062435 REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS Spire Biomedical, Inc. NFK Class II 2006-12-05
K061937 COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON Cook Endoscopy KNQ Class II 2006-12-01
K063220 DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000 Intuitive Surgical, Inc. NAY Class II 2006-12-01
K062340 CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM Cardio-Optics, Inc. LYK Class II 2006-11-30
K062833 POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM Vidacare Corporation FCF Class II 2006-11-30
K062399 ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE Rockwell Medical Technologies, Inc. KPO Class II 2006-11-17
K060907 KARL STORZ VIDEO GASTROSCOPES KARL STORZ Endoscopy-America, Inc. FDS Class II 2006-11-09
K062671 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE) Kendall MSD Class II 2006-11-03
K062081 LITHOGOLD Tissue Regeneration Technologies, Inc. LNS Class II 2006-11-02
K052267 SUPERCATH V Togo Medikit Co., Ltd. FIE Class II 2006-10-27
K061899 EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM Advanced Sterilization Products FEB Class II 2006-10-26
K062832 VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138 C.R. Bard, Inc. KNW Class II 2006-10-20
K062147 INTEGRA SL Direx Systems Corp. LNS Class II 2006-10-20
K062079 XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210 Baxter Healthcare Corporation KDI Class II 2006-10-19
K062090 PRISMA SYSTEM R03.10A Gambro Renal Products KDI Class II 2006-10-18
K062786 MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd. NEZ Class II 2006-10-18
K062240 CAREVENT Chief Medical, LLC KNY Class II 2006-10-16
K052229 COLOPLAST OSTOMY ROD, MODEL 12814 Coloplast Corp. EZP Class II 2006-10-13
K062805 MODIFICATION TO ENDO-EASE Spirus Medical, Inc. FED Class II 2006-10-13
K062895 XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII Dutch Ophthalmic Research Center International BV MPA Class II 2006-10-13
K060458 MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR Langford IC Systems, Inc. FEB Class II 2006-10-12
K062727 CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE Medtronic Vascular GCJ Class II 2006-10-11
K053585 VANGUARD REPROCESSED SUTURE PASSER Ascent Healthcare Solutions NLM Class II 2006-10-11
K062209 BASX BLADELESS TROCAR Ethicon Endo-Surgery, LLC GCJ Class II 2006-10-10
K062061 URASSIST Preferred Medical Devices, Inc. NZU Class I 2006-10-05
K062779 DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP) New Wave Surgical Corporation GCJ Class II 2006-10-05
K062244 OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR Arthrocare Corp. OCW Class II 2006-10-02
K062725 MAXIFLEX-SEMI FLEX SCOPE Technology Delivery Systems, Inc. FGB Class II 2006-09-29
K061548 STRYKER URETERAL ILLUMINATION SYSTEM IV Stryker Corp. FCS Class II 2006-09-28
K061770 ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM Ethicon Endo-Surgery, Inc. OCW Class II 2006-09-25
K062049 EVIS EXERA II 180 SYSTEM Olympus Medical Systems Corporation NWB Class II 2006-09-22
K061787 MAXFORCE TTS SINGLE-USE BALLOON DILATOR Boston Scientific Corp KNQ Class II 2006-09-21
K060944 NUTRISAFE 2 Vygon Corp. FPD Class II 2006-09-15
K061515 RENALSOFT Baxter Healthcare Corp KPF Class II 2006-09-11
K061432 HOSPIRA ENTERAL FEEDING SET, MODEL 20640 Hospira, Inc. KNT Class II 2006-09-11
K060333 DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM Dialysis Services, Inc. FIN Class II 2006-09-08
K060182 TRUMPET VALVE HANDLE WITH 3-METRE TUBING, SINGLE SPIKE, 5MM CANNULA, TRUMPET VALVE HANDLE WITH 3-METRE TUBING, DOUBLE Australian Surgical Devices GCJ Class II 2006-09-07
K060623 SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE Cook Ireland, Ltd. FER Class II 2006-09-06
K062159 RB12 SUCTION RECTAL BIOPSY SYSTEM Aus Systems Pty , Ltd. FCK Class II 2006-09-05
K062326 AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE United States Surgical, A Division of Tyco Healthc GCJ Class II 2006-09-01
K061231 WELLFLEX BILIARY RX STENT SYSTEM Boston Scientific Corp FGE Class II 2006-09-01
K060288 RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS Spire Biomedical, Inc. MSD Class II 2006-09-01
K061555 ANCHOR LAPARSCOPIC TISSUE RETIEVAL SYSTEM Anchor Products Co. GCJ Class II 2006-08-31
K061566 PRIMUS GPS BILIARY STENT SYSTEM Ev3, Inc. FGE Class II 2006-08-31
K061666 CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEX Mauna Kea Technologies GCJ Class II 2006-08-24
K061541 KSEA BIPOLAR ELECTROTOME Ksea FAS Class II 2006-08-21
K061918 FOLEY CATHETERS WITH TEMPERATURE PROBE GE Healthcare EYC Class II 2006-08-18
K060923 NAVIAID BGE DEVICE, MODEL 21-001 Smart Medical Systems , Ltd. FDA Class II 2006-08-15
K060557 SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS06120060 Idev Technologies, Inc. FGE Class II 2006-08-15
K062259 ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 Iscience Surgical MPA Class II 2006-08-15
K060624 MARATHON STENT WITH FUSION TECHNOLOGY Cook Ireland, Ltd. FGE Class II 2006-08-04
K060972 KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY) Kendall MSD Class II 2006-08-04
K060235 ENDO-EASE ENDOSCOPIC OVERTUBE Spirus Medical, Inc. FDA Class II 2006-08-04
K061837 NXSTAGE CARTRIDGE EXPRESS Nxstage Medical, Inc. KDI Class II 2006-07-31
K062050 FLEXVIEW SYSTEM Boston Scientific GCJ Class II 2006-07-31
K061180 KSEA ROTOCUT G1 ELECTROMECHANICAL MORCELLATOR KARL STORZ Endoscopy-America, Inc. GCJ Class II 2006-07-27
K060233 TROKAMED GMBH ENDOSCOPES AND ACCESSORIES Trokamed GmbH GCJ Class II 2006-07-19
K053547 SMARTPILL GI MONITORING SYSTEM The Smartpill Corporation NYV Class II 2006-07-18
K060897 EMBEDDING TOOL, MODEL TE-1000 Medigroup, Inc. FJS Class II 2006-07-18
K060384 CORAMATE/SPIROTOME SYSTEM Medinvents KNW Class II 2006-07-13
K060942 WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS Bob J. Johnson & Associates FIP Class II 2006-07-07
K061222 INJECTRA INJECTION NEEDLE Medi-Globe Corp. FBK Class II 2006-07-03
K061333 URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12 Uroplasty, Inc. NAM Class II 2006-07-03
K061292 STATARIUS, MODEL 001 003 Kinetic Surgical, LLC GCJ Class II 2006-07-03
K061570 I-STYLE BONE MARROW ASPIRATION NEEDLE Busse Hospital Disposables, Inc. KNW Class II 2006-07-03
K061646 LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES Laserscope FBO Class II 2006-06-27

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