meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
45
Latest Decision
2012-06-11

Clearances · page 30 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K121240 REPROCESSED ENDOSCOPIC TROCARS Sterilmed, Inc. NLM Class II 2012-06-11
K112860 PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER Coloplast A/S KNT Class II 2012-06-08
K120303 CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM Cybersonics, Inc. FFK Class II 2012-06-05
K121135 THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE Thd Spa FER Class II 2012-06-01
K120084 ENDOSCOPIC RETRIEVAL DEVICE United States Endoscopy Group, Inc. OCZ Class II 2012-05-30
K112621 WIS1000 Foreseeson Custom Displays, Inc. GCJ Class II 2012-05-30
K121380 WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT Teleflexmedical, Inc. GCJ Class II 2012-05-25
K120333 PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY Gambro Renal Products KPO Class II 2012-05-25
K120587 AMT T-FASTENER ANCHOR KIT Applied Medical Technology, Inc. KGC Class II 2012-05-25
K120130 FALLER TROCAR Medigroup, Inc. FJS Class II 2012-05-21
K112698 CONCENTRIC BALLOON GOOGLE United States Endoscopy Group, Inc. ODC Class II 2012-05-18
K120299 SRS ENDOSCOPIC STAPLING SYSTEM Medigus , Ltd. ODE Class II 2012-05-18
K111450 MIROCAM CAPSULE ENDOSCOPE SYSTEM Intromedic Co., Ltd. NEZ Class II 2012-05-18
K120440 PRESTO BREAST BIOPSY DEVICE Sontina Medical, LLC KNW Class II 2012-05-17
K113050 CLEARPATH LOWER GI Easyglide , Ltd. FDF Class II 2012-05-16
K113166 CLEARPATH UPPER GI Easyglide , Ltd. FDS Class II 2012-05-16
K120160 ROCAMED ROCAUS PLATINUM Promepla Sam KNY Class II 2012-05-14
K120821 LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM Misder, LLC OCT Class II 2012-05-11
K112511 DOBBHOFF DUAL PORT FEEDING TUBE Covidien Lp, Formerly Registered AS Kendall KNT Class II 2012-05-11
K120215 SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE Intuitive Surgical, Inc. NAY Class II 2012-04-30
DEN100016 PROSTATE MECHANICAL IMAGER Artann Laboratories, Inc. OQT Class II 2012-04-27
K112314 NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER Nephros, Inc. KDI Class II 2012-04-27
K113119 ENDOGATOR ADVANTAGE IRRIGATION PUMP Byrne Medical, Inc. OCX Class II 2012-04-27
K112342 FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM Convatec, Inc. KNT Class II 2012-04-26
K120452 FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM Flexible Stenting Solutions, Inc. FGE Class II 2012-04-24
K112734 APLAN A.V. FISTULA NEEDLE SET Aplan Well Enterprise Co., Ltd. FIE Class II 2012-04-24
K113719 SAFETY SCREW CONNECTOR Abbott Laboratories KNT Class II 2012-04-20
K120208 CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES Mauna Kea Technologies OWN Class II 2012-04-20
K120182 NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES Neomed, Inc. KNT Class II 2012-04-19
K113424 LOFRIC SINGLE USE URINARY CATHETER Astra Tech AB EZD Class II 2012-04-17
K120403 SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER Transenterix, Inc. GCJ Class II 2012-04-16
K111997 IMAGE1 GI CCU MODEL 22203020-114 KARL STORZ Endoscopy-America, Inc. FET Class II 2012-04-06
K111480 MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM Technology Delivery Systems, Inc. FGB Class II 2012-04-04
K120674 MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER Covidien MPB Class II 2012-04-04
K111274 JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038 Jetprep, Ltd. OCX Class II 2012-04-04
K111058 URETRON MODEL URT Med-Sonics Corp. FFK Class II 2012-03-30
K120088 MCOMPASS ANORECTAL MANOMETRY SYSTEM Medspira, LLC KLA Class II 2012-03-29
K112863 ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, ENTERAL EXTENSION SET WITH MINITUBE CONN Acta Medical, LLC KNT Class II 2012-03-29
K120005 ACDS Isopure, Corp. KPO Class II 2012-03-29
K120123 AQUASHIELD CO2 SYSTEM United States Endoscopy Group, Inc. FEQ Class II 2012-03-28
K120061 WOUND PROTECTOR Covidien, Formerly US Surgical A Divison of Tyco H GCJ Class II 2012-03-27
K112411 MAMMOTOME ELITE BIOPSY SYSTEM Devicor Medical Products, Inc. KNW Class II 2012-03-20
K111756 V1 SYSTEM Olympus Medical Systems Corp. FDF Class II 2012-03-20
K112268 CODAN SAFEFEED ENTERAL FEEDING RESERVOIR Codan US Corp. KNT Class II 2012-03-19
K113854 PLEURX PERITONEAL CATHETER SYSTEM Care Fusion PNG Class II 2012-03-19
K120608 ENDOSCOPIC APPLICATOR Micromedics, Inc. GCJ Class II 2012-03-15
K113354 VETA PERITONEAL DIALYSIS CATHETER Pfm Medical, Inc. FJS Class II 2012-03-13
K112659 SURGICAL RETRACTORS Surgical Innovations Plc GCJ Class II 2012-03-09
K113487 HEMO-CATH 10F, HEMO-CATH 12.5F Medical Components, Inc. MSD Class II 2012-03-09
K113872 THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE Vidacare Corporation KNW Class II 2012-03-08
K120505 FRESENIUS 2008T HEMODIALYSIS MACHINE Fresenius Medical Care North America, Design Cente KDI Class II 2012-03-06
K111947 DUET MAGNA Direx Systems Corp. LNS Class II 2012-03-01
K113203 SONY LMD-2451MT LCD MONITOR Sony Electronics, Inc. GCJ Class II 2012-02-24
K100624 INVENDO C20 COLONOSCOPY SYSTEM Invendo Medical Gbmh FDF Class II 2012-02-23
K120189 BONETRAP Berni Farns Incorporated KNW Class II 2012-02-22
K110179 INCONTROL Incontrol Medical, LLC KPI Class II 2012-02-22
K120272 AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET Kentec Medical, Inc. KNT Class II 2012-02-17
K120147 ACE STAPLER AND CARTRIDGE Barosense, Inc. OCW Class II 2012-02-17
K111521 WAVES Waters Medical Systems, LLC KDN Class II 2012-02-16
K112680 EVIS EXERA III VIDEO SYSTEM Olympus Medical Systems Corporation FDF Class II 2012-02-16
K113634 INJEKT CYSTO FLEXIBLE INJECTION NEEDLE Cook Ireland, Ltd. FBK Class II 2012-02-14
K111405 BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER, Hangzhou Bever Medical Devices Co., Ltd. GBM Class II 2012-02-13
K112994 CRE DITATATION BALLON Boston Scientific Corporation FGE Class II 2012-02-10
K112106 NAVIAID ICVI-F,S,B,R DEVICE Smart Medical Systems , Ltd. ODC Class II 2012-02-06
K120017 FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM Fresenius Medical Care North America KDI Class II 2012-02-02
K112427 BICARB MIXING AND DISTRIBUTION SYSTEM Isopure, Corp. FIN Class II 2012-01-26
K112576 ENDOCHOICE WATER BOTTLE CAP SYSTEM Endochoice, Inc. FEQ Class II 2012-01-25
K111407 TRIPORT, TRIPORT+, TRIPORT15, QUADPORT Advanced Surgical Concepts OTJ Class II 2012-01-18
K110480 PDE PHOTODYNAMIC EYE Hamamatsu Photonics K.K. OWN Class II 2012-01-13
K113679 LUCEA LED SURGICAL LIGHT SYSTEM Maquet S.A.S. NTN Class II 2012-01-12
K113351 CORTRAK ENTERAL ACCESS DEVICE Corpak Medsystems KNT Class II 2012-01-10
K111165 KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE KARL STORZ Endoscopy-America, Inc. ODA Class II 2012-01-06
K111149 HANAROSTENT BILIARY (NNN) M.I.Tech Co., Ltd. FGE Class II 2011-12-30
K112522 FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM Flexible Stenting Solutions, Inc. FGE Class II 2011-12-30
K112543 WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM Boston Scientific Corporation FGE Class II 2011-12-29
K110639 ENDOWRIST ONE VESSEL SEALER Intuitive Surgical, Inc. NAY Class II 2011-12-28
K113427 FRESENIUS 2008T HEMODIALYSIS MACHINE Fresenius Medical Care North America KDI Class II 2011-12-21
K111013 ACEM Sandhill Scientific, Inc. FFZ Class II 2011-12-19
K110793 AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS Ameco Medical Industries MPB Class II 2011-12-16
K102712 MED GRAVITY SET, IMED PUMP SET Imed Technology, Inc. KNT Class II 2011-12-16
K111651 SPLIT CATH III Medical Components, Inc. MSD Class II 2011-12-08
K112208 INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES Intuitive Surgical, Inc. NAY Class II 2011-12-08
K102756 SURECORE BIOPSY DEVICE Chest Innovations, Inc. KNW Class II 2011-11-29
K113209 CHIBA SONO Pajunk GmbH KNW Class II 2011-11-21
K102833 DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS Foshan Nanhai Bai HE Medical Technology Co., Ltd. MPB Class II 2011-11-18
K102741 ENTERAL FEEDING BAG AND SETS Shandong Weigao Group Medical Polymer Co., Ltd. KNT Class II 2011-11-08
K112945 ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM Inrad, Inc. KNW Class II 2011-11-03
K111648 BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR Bracco Diagnostic, Inc. FCX Class II 2011-11-03
K111028 EUS BALLOON United States Endoscopy Group, Inc. FDF Class II 2011-11-01
K103155 SUMO ACCESS AND TISSUE RESECTION SYSTEM Apollo Endosurgery, Inc. ODC Class II 2011-10-28
K112178 JMS APHERESIS NEEDLE SET WINGEATER(R) V2 JMS North America Corporation FIE Class II 2011-10-27
K112701 CHARGER BALLOON DILATATION CATHETER Boston Scientific FGE Class II 2011-10-25
K111948 WINGEATER V2 JMS North America Corporation FIE Class II 2011-10-24
K111639 FRESENIUS 2008T HEMODIALYSIS MACHINE Fresenius Medical Care KDI Class II 2011-10-21
K112468 THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE Regulatory Specialists, Inc. KNW Class II 2011-10-20
K110804 AMT G-J TUBE Applied Medical Technology, Inc. KNT Class II 2011-10-19
K111766 SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS Idev Technologies, Inc. FGE Class II 2011-10-19
K112358 UNIMAX TROCAR SYSTEM Unimax Medical Systems, Inc. GCJ Class II 2011-10-17
K100163 NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX Vygon Corp. FPD Class II 2011-10-13
K112263 MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY Intuitive Surgical, Inc. NAY Class II 2011-10-07

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