meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
52
Latest Decision
2009-10-30

Clearances · page 34 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K092342 SMARTPILL GI MONITORING SYSTEM, VERSION 2.0 The Smartpill Corporation NYV Class II 2009-10-30
K092309 SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L Olympus Medical Systems Corporation KNS Class II 2009-10-30
K092205 PALINDROME P HEMODIALYSIS CATHETER Covidien Lp, Formerly Registered AS Kendall MSD Class II 2009-10-30
K091305 CLEARPATH Easyglide , Ltd. FDF Class II 2009-10-23
K092418 ENTRACARE GASTROSTOMY FEEDING TUBE Entracare, LLC KNT Class II 2009-10-23
K092221 COLONIC SPLINTING OVERTUBE, MODEL 00711145 United States Endoscopy Group, Inc. FED Class II 2009-10-20
K091516 WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR Well Lead Medical Co., Ltd. EZL Class II 2009-10-16
K092156 CAD 12, COLONOSCOPY ASSIST DEVICE Softscope Medical Technologies, Inc. FED Class II 2009-10-14
K091767 3 WAY SILICONE FOLEY BALLOON CATHETER Cook Urological, Inc. EZL Class II 2009-10-09
K092049 IYUNNI 3ID TRI-FUNNEL GASTROSTOMY TUBE KIT Sainath Intellectual Properties, LLC KNT Class II 2009-10-09
K091962 POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 Lumenis, Inc. ODF Class II 2009-09-30
K091637 CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 Corpak Medsystems KNT Class II 2009-09-29
K091697 SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015 Transenterix, Inc. GCJ Class II 2009-09-28
K083840 MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE Msi Medserv International Deutschland GmbH GCM Class II 2009-09-28
K090557 GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM Given Imaging , Ltd. NSI Class II 2009-09-28
K090183 HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON Cook Endoscopy KNQ Class II 2009-09-25
K092059 RP CUTTING NEEDLE Riverpoint Medical KNW Class II 2009-09-24
K091930 ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB Anchor Products Co. GCJ Class II 2009-09-23
K091759 SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H Olympus Medical Systems Corporation KNT Class II 2009-09-18
K091350 ESTECH HAWKEYE INTRODUCER SYSTEMS Endoscopic Technologies, Inc. D/B/A Estech GCJ Class II 2009-09-15
K081996 FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM Flexible Stenting Solutions, Inc. FGE Class II 2009-09-15
K091968 KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C KARL STORZ Endoscopy-America, Inc. FCW Class II 2009-09-14
K091211 EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORS Ethicon Endo-Sugery, LLC GCJ Class II 2009-09-04
K091495 SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A Olympus Medical Systems Corporation LQR Class II 2009-09-03
K091869 SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS Covidien Lp, Formerly Registered AS United States GCJ Class II 2009-09-01
K091600 DIRECTVISION GUIDE SYSTEM Percuvision, LLC FGC Class II 2009-08-25
K091306 AMSURE PVC INTERMITTENT CATHETER Amsino International, Inc. EZD Class II 2009-08-21
K090960 VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, Hollister, Inc. GBM Class II 2009-08-20
K090576 FOOTPRINT URINARY DRAINAGE CATHETER Footprint Medical EZD Class II 2009-08-12
K091699 AMSURE HYDROPHILIC LATEX FOLEY CATHETER Amsino International, Inc. EZL Class II 2009-08-10
K090002 ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A Baxter Healthcare Corp KPO Class II 2009-08-07
K091773 FUJINON STERILE OVERTUBES Fujinon, Inc. FED Class II 2009-08-07
K091648 NURSE'S ASSISTANT O.R. CONTROL SYSTEM ,1.8 Conmed Integrated Systems (Cmis) GCJ Class II 2009-08-05
K090210 MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM Olympus Medical Systems Corporation NEZ Class II 2009-07-29
K091405 PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT Given Imaging , Ltd. NEZ Class II 2009-07-29
K082093 BULLSEYE BILIARY STENT SYSTEM Squareone FGE Class II 2009-07-29
K091829 PLS PORTABLE LIGHT SOURCE Optim, Inc. NTN Class II 2009-07-28
K091519 HAEMOBAND MULTI-LIGATOR Haemoband Surgical, Ltd. FHN Class II 2009-07-28
K083614 SONOLITH I-SYS LITHOTRIPER Technomed Medical Systems, SA LNS Class II 2009-07-27
K090879 INSUFLOW CO2IONSHIELD Lexion Medical, LLC FCX Class II 2009-07-23
K091355 DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998 Conmed Endoscopic Technologies, Inc. FDI Class II 2009-07-22
K090902 SPIDER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, MODEL 90001, 90002, 90003 Transenterix, Inc. GCJ Class II 2009-07-22
K091832 ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER Endogastric Solutions, Inc. OCW Class II 2009-07-22
K090485 COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003 Percutaneous Systems, Incorporated LQR Class II 2009-07-22
K090830 LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP Laborie Medical Technologies, Ltd. FBK Class II 2009-07-21
K091760 DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS) Dermaport, Inc. MSD Class II 2009-07-20
K083704 NUTRAC PELVATOR, MODEL PEL 200 Verity Scientific , Ltd. KPI Class II 2009-07-14
K083712 WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS Dipure, LLC FIP Class II 2009-07-10
K091515 SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM Novadaq Technologies, Inc. GCJ Class II 2009-07-09
K091783 THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM Avantis Medical Systems, Inc. FDF Class II 2009-07-07
K090792 MITAKA UNIARM Mitaka Kohki Co., Ltd. GCJ Class II 2009-07-06
K090851 DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R) Byrne Medical, Inc. ODC Class II 2009-07-02
K091391 UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518 Uroplasty, Inc. FBK Class II 2009-06-30
K090885 NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER Nephros, Inc. FIP Class II 2009-06-29
K090980 HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L Olympus Winter & Ibe GmbH NWB Class II 2009-06-29
K090583 ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 Apollo Endosurgery, Inc. KGE Class II 2009-06-26
K083685 ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285 Mri Manufacturing and Research, Inc. KNT Class II 2009-06-25
K091245 COSTORSOL Preservation Solutions, Inc. KDN Class II 2009-06-17
K091490 FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES Thd Spa FER Class II 2009-06-11
K083292 HABIB ENDOHPB Emcision , Ltd. KNS Class II 2009-06-10
K083275 PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 Max Endoscopy, Inc. KNS Class II 2009-06-09
K091340 THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350 Boston Scientific Corp FPD Class II 2009-06-09
K083158 EXALIS, SOFTWARE VERSION 1.15 Gambro, Inc. KDI Class II 2009-06-05
K090611 REVOLUTION FULL CORE BIOPSY Inrad KNW Class II 2009-06-04
K090430 BACKSTOP AND BACKSTOP INJECTOR Pluromed, Inc. ONJ Class II 2009-06-02
K083598 KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION KARL STORZ Endoscopy-America, Inc. ODA Class II 2009-05-29
K090432 HEMORPEX SYSTEM Angiologica B. M. Srl FER Class II 2009-05-29
K090262 PERCUCATH URINARY CATHETER Percuvision, LLC EZL Class II 2009-05-28
K090979 DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES Encision, Inc. GCJ Class II 2009-05-28
K090528 DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT C.R. Bard, Inc. MSD Class II 2009-05-28
K082589 BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034 Barosense, Inc. FED Class II 2009-05-22
K091417 SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A Terumo Corp. OCY Class II 2009-05-22
K090340 FREEHAND Prosurgics Limited GCJ Class II 2009-05-22
K091070 MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM Sierra Scientific Instruments, Inc. FFX Class II 2009-05-19
K090196 EG-3670URK Pentax Medical Company ODG Class II 2009-05-19
K090197 EG-3870UTK Pentax Medical Company ODG Class II 2009-05-19
K090800 VS-100 ILLUMINATION AND IMAGING SYSTEM Schoelly Imaging, Inc. FET Class II 2009-05-18
K090270 BACKSTOP CATHETER, MODEL 60-0000-3100 Pluromed, Inc. KOD Class II 2009-05-15
K090470 AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES Covidien OCW Class II 2009-05-14
K090601 FSC 2 Schoelly Imaging, Inc. NTN Class II 2009-05-11
K090338 ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE Reprocessing Products Corp MSY Class II 2009-05-08
K091257 MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM Medi-Globe Corporation FCG Class II 2009-05-08
K082497 INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT Intuitive Surgical, Inc. NAY Class II 2009-05-07
K090677 INNOPORT LAPAROSCOPIC ACCESS DEVICE Innovia, LLC GCJ Class II 2009-05-07
K090559 FOOTPRINT MEDICAL SILICONE FEEDING TUBE Footprint Medical KNT Class II 2009-05-04
K090217 BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070 Coloplast A/S FBK Class II 2009-04-23
K090116 FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15 Fujinon, Inc. FDF Class II 2009-04-22
K083374 WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM Boston Scientific Corp FGE Class II 2009-04-22
K090814 MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 Gyrus Acmi, Inc. FAJ Class II 2009-04-20
K090631 PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS PAJUNK GmbH Medizintechnologie GCJ Class II 2009-04-16
K090121 PRE-FILLED CATHETER INFLATION SYRINGE Avail Medical Products, Inc. KNY Class II 2009-04-15
K090148 PROGUIDE CHRONIC DIALYSIS CATHETER Merit Medical Systems, Inc. MSD Class II 2009-04-13
K090663 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS American Medical Systems, Inc. FAE Class II 2009-04-09
K083627 WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540 Boston Scientific Corporation FGE Class II 2009-04-07
K082796 SOPRO 184 CAMERA Sopro GCJ Class II 2009-04-01
K082719 NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P NIKKISO CO., LTD. KOC Class II 2009-03-30
K083802 SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025 Medi-Globe Corporation FCG Class II 2009-03-20
K083675 POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER C.R. Bard, Inc. NIE Class II 2009-03-19
K082735 STONE GRASPING BASKET, MODEL PD-T1 2115 Sialo Technology, Ltd. GCJ Class II 2009-03-13
K081740 HEMOBAND, MODELS HB-NS AND HB-NSXL Innovations For Access, Inc. KOC Class II 2009-03-12

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