meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
56
Latest Decision
2013-09-19

Clearances · page 28 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K124024 APD LUER-LOCK ADAPTER Fresensius Medical Care North America KDJ Class II 2013-09-19
K132314 MEDLINE ANTI-REFLUX VALVE Medline Industries, Inc. FEG Class II 2013-09-18
K130873 VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M Vital Access PFH Class II 2013-09-13
K124031 DA VINCI FLUORESCENCE IMAGING VISION SYSTEM Intuitive Surgical, Inc. OWN Class II 2013-09-13
DEN130023 UROLIFT SYSTEM Neotract, Inc. PEW Class II 2013-09-13
K123630 FRESENIUS LIBERTY CYCLER Fresenius Medical Care North America, Design Cente FKX Class II 2013-09-09
K130792 LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM C.R. Bard, Inc. FGE Class II 2013-08-30
K130266 ENDOWRIST ONE VESSEL SEALER Intuitive Surgical, Inc. NAY Class II 2013-08-29
K131611 FRESENIUS DRY ACID DISSOLUTION UNITS Fresenius Medical Care North America KPO Class II 2013-08-29
K131780 EVIS EXERA III VIDEO SYSTEM Olympus Medical Systems Corp. FDF Class II 2013-08-29
K132535 AUTOBAND LIGATOR Endochoice, Inc. MND Class II 2013-08-23
K130951 SIM Simavita Pty Limited KPN Class II 2013-08-22
K132169 SURGIQUEST AIRSEAL IFS Surgiquest, Inc. GCJ Class II 2013-08-22
K131803 GUARDIAN URETHRAL SHEATH Solace Therapeutics KNY Class II 2013-08-20
K121736 PERF-GEN PULSATILE PERFUSION SOLUTION Waters Medical Systems, LLC KDL Class II 2013-08-16
K131052 TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS) Actuated Medical, Inc. KNT Class II 2013-08-16
K123864 GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM Given Imaging , Ltd. NEZ Class II 2013-08-12
K131532 ELECTROMAGNETIC TRANSMITTING STYLET Corpak Medsystems KNT Class II 2013-08-12
K130484 MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER Boston Scientific Corp FGE Class II 2013-08-09
K131642 RSH BILIARY STONE REMOVAL DEVICE Rsh, LLC LQR Class II 2013-08-07
K130148 FOREIGN BODY HOOD United States Endoscopy Group, Inc. FDS Class II 2013-08-07
K123047 BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET Bracco Diagnostic, Inc. FCX Class II 2013-08-06
K121370 VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE Vectec FHO Class II 2013-08-02
K130826 PASSPORT ROBOTIC REDUCER CAP; PASSPORT STOPCOCK WITH ROTATING MALE LUER Stryker Endoscopy GCJ Class II 2013-08-01
K122532 DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES Intuitive Surgical, Inc. NAY Class II 2013-07-30
K122091 COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY Cook, Inc. MPB Class II 2013-07-29
K123768 RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM STERIS Corporation NZA Class II 2013-07-26
K131814 AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER Ameco Medical Industries MSD Class II 2013-07-26
K130623 BARRX CHANNEL RFA ENDOSCOPIC CATHETER Covidien, LLC KNS Class II 2013-07-26
K131688 NEOCLOSE HASSON, NEOCLOSE UNIVERSAL Neosurgical, Ltd. GCJ Class II 2013-07-18
K130906 ENDOFLIP CATHETER Crospon, Ltd. FFX Class II 2013-07-17
K130460 NXSTAGE DOSING CALCULATOR Nxstage Medical, Inc. FKP Class II 2013-07-11
K131282 NEXUS HEMORRHOID LIGATOR Inx Medical FHN Class II 2013-07-11
K131072 ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC Coloplast A/S OCY Class II 2013-07-09
K124035 2008K@HOME HEMODIALYSIS MACHINE Fresenius Medical Care North America ONW Class II 2013-07-03
K122653 MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES Kimberly-Clark Corporation KNT Class II 2013-06-26
K123288 HEMOCONCENTRATOR Maquet Cardiopulmonary, AG KDI Class II 2013-06-26
K130819 CLL- V1 LIGHT SOURCE Olympus Winter & Ibe GmbH NTN Class II 2013-06-19
K124018 AMIA AUTOMATED PD SYSTEM Deka Research & Development Corp. FKX Class II 2013-06-14
K121618 BEL-GEN COLD STORAGE SOLUTION Waters Medical Systems, LLC KDL Class II 2013-06-14
K123292 T3 Medcomp NIE Class II 2013-06-11
K131115 ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIRE Nds Surgical Imaging GCJ Class II 2013-06-07
K130726 DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK Intuitive Surgical, Inc. NAY Class II 2013-06-07
K130804 UROMAX ULTRA BALLOON DILATATION CATHETER Boston Scientific Corporation EZN Class II 2013-05-22
K123428 MIROCAM CAPSULE ENDOSCOPE SYSTEM Intromedic Co., Ltd. NEZ Class II 2013-05-20
K122417 SCOPEVALET DISPOSABLE BIOPSY VALVE The Ruhof Corp. OCX Class II 2013-05-17
K130909 GATEWAY ADVANAGE Y-ADAPTER Boston Scientific Corp OCX Class II 2013-05-16
K130729 EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER Dornier Medtech Systems LNS Class II 2013-05-14
K122785 HYDROSIL; MAGIC; PERSONAL CATHETER Rochester Medical Corp. EZD Class II 2013-05-14
K130282 REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT Remington Medical, Inc. KNW Class II 2013-05-13
K130192 NEXTSTEP RETROGRADE Arrow International, Inc. MSD Class II 2013-05-10
K131020 TEMPERATURE SENSOR CATHETER Degania Silicone , Ltd. EZL Class II 2013-05-09
K122343 PUREFLUX-H HEMODIALYZER Nipro Medical Corporation KDI Class II 2013-05-07
K130591 SUPERA VERITAS Idev Technologies, Inc. FGE Class II 2013-05-02
K130039 REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER Gambro Renal Products, Inc. KDI Class II 2013-05-02
K122347 ELISIO-H AND ELISIO-M HEMODIALYZERS Nipro Medical Corporation KDI Class II 2013-05-01
K123421 OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM Olympus Medical Systems Corp. NEZ Class II 2013-04-29
K123601 SINGLE USE REPOSITIONABLE CLIP Olympus Medical Systems Corp. PKL Class II 2013-04-29
K123282 DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS Ultrapure & Industrial Services, LLC FIP Class II 2013-04-25
K122051 NXSTAGE SYSTEM ONE Nxstage Medical, Inc. KDI Class II 2013-04-23
K123716 AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT Applied Medical Technology, Inc. KNT Class II 2013-04-19
K130441 FALLER STYLET Medionics International, Inc. FJS Class II 2013-04-19
K130489 ELECTRODE, FLEXIBLE SUCTION COAGULATOR Optim, LLC FEH Class II 2013-04-19
K123676 CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES Mauna Kea Technologies OWN Class II 2013-04-18
K130100 COMINED STANDARD SOLUTION Mesa Laboratories, Inc. FKH Class II 2013-04-18
K123280 NEOCLOSE HASSON, NEOCLOSE UNIVERSAL Neosurgical, Ltd. GCJ Class II 2013-04-18
K123467 VS3 Visionsense, Ltd. GCJ Class II 2013-04-17
K123804 INSTAFLO BOWEL CATHETER SYSTEM KIT Hollister, Inc. KNT Class II 2013-04-17
K130718 PEERSCOPE SYSTEM Peermedical , Ltd. FDF Class II 2013-04-16
K130121 SHORT PORT BLUNT TIP TROCAR Boston Scientific Corporation GCJ Class II 2013-04-11
K122505 SINGLE USE PRELOADED SPHINCTEROTOME V Olympus Medical Systems Corp. KNS Class II 2013-04-11
K122470 PENTAX EPK-I5010 VIDEO PROCESSOR Pentax Medical PEA Class II 2013-04-10
K122194 LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE Everyway Medical Instruments Co.,Ltd KPI Class II 2013-04-04
K130423 THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525 Richard Wolf Medical Instruments Corp. FET Class II 2013-04-03
K123943 AMECATH DUAL LUMEN HEMODIALYSIS CATHETER Ameco Medical Industries MSD Class II 2013-04-02
K130483 BOEHRINGER GASTRIC SIZING TUBE Boehringer Laboratories, LLC KNT Class II 2013-03-28
K124059 AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT) Lauer Membran Wassertechnik GmbH FIP Class II 2013-03-25
K123013 ENDOSCOPIC INTRODUCER Novadaq Technologies, Inc. FED Class II 2013-03-22
K130247 PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS Pentax of America, Inc. ODG Class II 2013-03-20
K130206 PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS Pentax of America, Inc. ODG Class II 2013-03-20
K123805 E-Z CHEK BLOOD LEAK TEST STRIPS Reprocessing Products Corp FJD Class II 2013-03-20
K121933 NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM) Marvao Medical Devices, Ltd. MSD Class II 2013-03-14
K130435 VERSAPORT V2 BLADELESS OPTICAL TROCAR Covidien, Formerly US Surgical A Divison of Tyco H GCJ Class II 2013-03-14
K123395 NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS Nxstage Medical, Inc. KDI Class II 2013-03-07
K120815 INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE Philips Medical Systems FPD Class II 2013-03-06
K123675 RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR Coloplast A/S FED Class II 2013-03-01
K121430 EVOLUTION BILIARY STENT SYSTEM Cook Ireland, Ltd. FGE Class II 2013-03-01
K123606 CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE Scion Medical Technologies, LLC KNW Class II 2013-03-01
K123751 LOFRIC SENSE Wellspect Healthcare EZD Class II 2013-02-28
K124052 OSTAVI HYDROPHILIC GUIDEWIRE Lake Region Medical OCY Class II 2013-02-26
K123835 2008 HEMODIALYSIS SORBENT SYSTEM Renal Solutions, Inc. FKT Class II 2013-02-15
K123840 CONNECT FOR DA VINCI SURGICAL SYSTEM(S) Intuitive Surgical, Inc. NAY Class II 2013-02-14
K123326 SHERPA PAK CARDIAC TRANSPORT SYSTEM Paragonix Technologies, Inc. MSB Class II 2013-02-06
K121409 ASAHI REXEED-SX/LX SERIES DIALYZER Asahi Kasei Medical Co., Ltd. KDI Class II 2013-02-06
K123704 AUTOMATED ENDOSCOPE LEAK TESTER Olympus Medical Systems Corp. PCV Class II 2013-02-04
K123170 VARI-PASS VARIABLE LENGTH ACCESS SHEATH Olympus Surgical Technologies America KNY Class II 2013-02-04
K123196 PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH Covidien MSD Class II 2013-01-31
K122172 SYSTEM 83 PLUS Custom Ultrasonics FEB Class II 2013-01-25
K123956 POWER LED 175 KARL STORZ Endoscopy-America, Inc. FCW Class II 2013-01-25
K123325 Medafor Direct Gas-Assisted Application System Medafor, Inc. GCJ Class II 2013-01-24

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