Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 50
- Latest Decision
- 2007-10-16
Clearances · page 37 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K071049 | DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR | Tyco Healthcare | EZL | Class II | 2007-10-16 |
| K071814 | LIGHT SABRE SPINAL ACCESS DEVICE | Minrad, Inc. | KNW | Class II | 2007-10-16 |
| K072715 | REALHAND HIGH DEXTERITY INSTRUMENTS | Novare Surgical Systems, Inc. | GCJ | Class II | 2007-10-16 |
| K063788 | REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS | Ascent Healthcare Solutions | NLM | Class II | 2007-10-15 |
| K070414 | GAMBRO CARTRIDGE BLOOD SETS | Gambro Renal Products | FJK | Class II | 2007-10-12 |
| K071057 | COLONIC & ENEMA NOZZLE | Tiller Mind Body, Inc. | KPL | Class II | 2007-10-05 |
| K072674 | KII TROCAR SYSTEM | Applied Medical Resources Corp. | GCJ | Class II | 2007-10-05 |
| K072024 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693 | Nipro Medical Corp. | FJK | Class II | 2007-10-04 |
| K070059 | REPROCESSED TROCARS | Ascent Healthcare Solutions | NLM | Class II | 2007-10-02 |
| K061519 | MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM | NIKKISO CO., LTD. | KDI | Class II | 2007-09-28 |
| K070881 | LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 | Sapimed S.P.A. | FHN | Class II | 2007-09-26 |
| K071553 | ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR | Ndo Surgical, Inc. | ODE | Class II | 2007-09-18 |
| K071832 | MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM | Medical Scientific, Inc. | LJH | Class II | 2007-09-18 |
| K071651 | EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES | Endogastric Solutions, Inc. | ODE | Class II | 2007-09-14 |
| K063481 | MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM | Abbott Vascular, Inc. | FGE | Class II | 2007-09-14 |
| K063259 | OLYMPUS CAPSULE ENDOSCOPE SYSTEM | Olympus Medical Systems Corporation | NEZ | Class II | 2007-09-14 |
| K072539 | CURE CATHETER | Cure Medical, LLC | EZD | Class II | 2007-09-13 |
| K072405 | USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE | Usgi Medical | FED | Class II | 2007-09-13 |
| K071145 | NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE | Nipro Medical Corporation | MPB | Class II | 2007-09-07 |
| K071854 | AQUADEX FLEXFLOW SYSTEM | Chf Solutions, Inc. | KDI | Class II | 2007-09-07 |
| K060676 | NES REPROCESSED ENDOSCOPIC TROCAR | Northeast Scientific, Inc. | NLM | Class II | 2007-09-07 |
| K072232 | GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL | Gambro Renal Products, Inc. | KDI | Class II | 2007-09-07 |
| K071167 | FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560 | Medigroup, Inc. | FJS | Class II | 2007-08-31 |
| K070579 | STORZ SLX-F2 STORM TOUCH | KARL STORZ Endoscopy-America, Inc. | LNS | Class II | 2007-08-30 |
| K071263 | NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500 | Nxstage Medical, Inc. | KDI | Class II | 2007-08-24 |
| K070158 | R-PORT LAPAROSCOPIC ACCESS DEVICE | Advanced Surgical Concepts | GCJ | Class II | 2007-08-23 |
| K071422 | 15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET | Rex Medical | MSD | Class II | 2007-08-22 |
| K071822 | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12 | Uroplasty, Inc. | NAM | Class II | 2007-08-20 |
| K070376 | CONMED LINVATEC 300W XENON LIGHT SOURCE | Conmed Linvatec | GCT | Class II | 2007-08-20 |
| K071518 | DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS | B. Braun Medizintechnologie GmbH | KDI | Class II | 2007-08-17 |
| K071496 | ICATH, STERILESURE | Colorado Catheter Company, Inc. | NWO | Class II | 2007-08-15 |
| K071756 | ENDOHUB- 1.0 ENDOSCOPIC VIDEO CAMERA SYSTEM WITH VIDEO CAPTURE | Pointe Conception Medical, Inc. | GCJ | Class II | 2007-08-15 |
| K070151 | INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER | Ethicon Endo-Surgery, LLC | OCW | Class II | 2007-08-15 |
| K070622 | NEOGUIDE ENDOSCOPY SYSTEM | Neoguide Systems, Inc. | FDF | Class II | 2007-08-14 |
| K071094 | MODIFICATION TO SOLAR GI | Medical Measurement Systems B.V. | FFX | Class II | 2007-08-13 |
| K070913 | SELF-LIGHT DISPOSABLE ANOSCOPE | Sapimed S.P.A. | FER | Class II | 2007-08-10 |
| K071298 | HF JUNIOR HEMOFILTER | Minntech Corp. | KDI | Class II | 2007-08-08 |
| K071571 | SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM | Surgiquest, Inc. | GCJ | Class II | 2007-07-30 |
| K063355 | D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW | Novosci Corp. | MPB | Class II | 2007-07-27 |
| K071191 | NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT | Novartis Nutrition Corp. | FPD | Class II | 2007-07-23 |
| K071292 | VIEW MD OFFICE SYSTEM, MODEL 41066.5540 | Richard Wolf Medical Instruments Corp. | GCJ | Class II | 2007-07-19 |
| K071423 | MEDLINE LATEX FOLEY CATHETER | Medline Industries, Inc. | EZL | Class II | 2007-07-18 |
| K070915 | SAPIMED DISPOSABLE SIGMOIDOSCOPE | Sapimed S.P.A. | KDM | Class II | 2007-07-06 |
| K070730 | FLEX-NECK ARC CATHETER | Medigroup, Inc. | FJS | Class II | 2007-07-03 |
| K071488 | REALHAND HIGH DEXTERITY (HD) INSTRUMENTS | Novare Surgical Systems, Inc. | GCJ | Class II | 2007-06-29 |
| K071066 | SPYCATCH STONE RETRIEVAL BASKET | Boston Scientific Corp | LQR | Class II | 2007-06-29 |
| K070572 | ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM | Ash Access Technology, Inc. | MSD | Class II | 2007-06-26 |
| K070610 | SKATER BILIARY CATHETER | Angiotech | FGE | Class II | 2007-06-21 |
| K071387 | FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB | Fresenius Medical Care North America | KPO | Class II | 2007-06-15 |
| K070449 | LUMILOC (TM) SAFETY INTRODUCER NEEDLE | Specialized Health Products International, Inc. | KNT | Class II | 2007-06-14 |
| K063876 | MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING | Medivators Reprocessing Systems | FEB | Class II | 2007-06-14 |
| K070198 | ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES AND ENDOPATH DEXTRUS FIXED-LENGTH ACCESS RETRACTORS, HAP02 | Ethicon Endo-Surgery, LLC | GCJ | Class II | 2007-06-13 |
| K071153 | GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE | Given Imaging , Ltd. | NSI | Class II | 2007-06-11 |
| K070320 | EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 | Edwards Lifesciences Services GmbH | KDI | Class II | 2007-06-07 |
| K062112 | SUNMED FOLEY CATHETERS | Sunmed, Inc. | EZL | Class II | 2007-06-04 |
| K070939 | SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM | Coloplast Manufacturing Us, LLC | FCM | Class II | 2007-06-01 |
| K070716 | IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL | KARL STORZ Endoscopy-America, Inc. | FET | Class II | 2007-05-31 |
| K062979 | THYROSAMPLER | Acd Medical Innovation Corp. | FCG | Class II | 2007-05-30 |
| K070739 | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 | Renal Solutions, Inc. | FKT | Class II | 2007-05-25 |
| K070124 | GASTROSTOMY REPLACEMENT TUBE, MODEL 253 | Degania Silicone , Ltd. | KNT | Class II | 2007-05-23 |
| K070234 | JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS | Jms North America Corp. | MPB | Class II | 2007-05-22 |
| K070827 | KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120 | KARL STORZ Endoscopy-America, Inc. | ODA | Class II | 2007-05-22 |
| K070759 | POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM | Vidacare Corporation | FCF | Class II | 2007-05-21 |
| K071048 | RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537 | Rubicor Medical, Inc. | KNW | Class II | 2007-05-15 |
| K062475 | LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM | The Laryngeal Mask Co., Ltd. | FFK | Class II | 2007-05-09 |
| K063742 | RESONANCE METALLIC URETERAL STENT | Cook Ireland, Ltd. | FAD | Class II | 2007-05-08 |
| K070475 | MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM | Given Imaging , Ltd. | NEZ | Class II | 2007-05-07 |
| K070331 | UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES | Laborie Medical Technologies | KPI | Class II | 2007-05-04 |
| K063233 | DELTACUT (APPARATUS AND CANNULA) | PAJUNK GmbH Medizintechnologie | KNW | Class II | 2007-04-30 |
| K070512 | MODIFICATION TO AQUADEX FLEXFLOW SYSTEM | Chf Solutions, Inc. | KDI | Class II | 2007-04-27 |
| K070879 | BARD MALECOT AND PEZZER DRAINS | C.R. Bard, Inc. | FEW | Class II | 2007-04-24 |
| K070222 | FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N | Fresenius Medical Care North America | KDI | Class II | 2007-04-24 |
| K070330 | THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM | Avantis Medical Systems, Inc. | FDF | Class II | 2007-04-24 |
| K070091 | COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208 | Cardinal Health, Inc. | KNW | Class II | 2007-04-18 |
| K062362 | SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS | Sarmed Srl | KLA | Class II | 2007-04-13 |
| K070671 | OPUS SMARTSTITCH SUTURE DEVICE | Arthrocare Corp. | OCW | Class II | 2007-04-06 |
| K070686 | MINI LAP INSTRUMENTS | Mini Lap Technologies, Inc. | OCW | Class II | 2007-04-05 |
| K070352 | MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM | Mini Lap Technologies, Inc. | OCW | Class II | 2007-04-05 |
| K063061 | CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 | Viasys Medsystems | KNT | Class II | 2007-04-02 |
| K070177 | FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES | Fresenius Medical Care North America | KPO | Class II | 2007-03-29 |
| K070712 | MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM | Surgical Innovations Group Plc | GCJ | Class II | 2007-03-28 |
| K063442 | ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR | Degania Silicone , Ltd. | EZL | Class II | 2007-03-26 |
| K063293 | EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE | Edwards Lifesciences Services GmbH | FJK | Class II | 2007-03-23 |
| K070509 | FISSO HOLDING SYSTEM | Baitella AG | GCJ | Class II | 2007-03-22 |
| K062720 | S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES | Richard Wolf Medical Instruments Corp. | FJL | Class II | 2007-03-22 |
| K070420 | BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 | United States Endoscopy Group, Inc. | ODD | Class II | 2007-03-19 |
| K063316 | FUJINON MODEL EG-530N TRANS NASAL INSERTION | Fujinon, Inc. | FDS | Class II | 2007-03-16 |
| K070048 | GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT | Marian Medical, Inc. | FCM | Class II | 2007-03-15 |
| K062222 | UNITIP HIGH RESOLUTION CATHETER | Unisensor AG | FFX | Class II | 2007-03-15 |
| K063859 | SURGIQUEST ELASTOMERIC OPTICAL TROCAR & CANNULA | Surgiquest, Inc. | GCJ | Class II | 2007-03-14 |
| K062875 | ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES | Endogastric Solutions, Inc. | OCW | Class II | 2007-03-09 |
| K070508 | BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR | C.R. Bard, Inc. | EZL | Class II | 2007-03-09 |
| K063504 | ECONOLITH EM1000 | Medispec, Ltd. | LNS | Class II | 2007-03-09 |
| K061766 | EXPRESSWAY INTERMITTENT CATHETER | Percutaneous Systems, Incorporated | EZD | Class II | 2007-03-09 |
| K070179 | TROKABONE, TROKABONE STERNAL | PAJUNK GmbH Medizintechnologie | FCG | Class II | 2007-03-07 |
| K063795 | GUARDIANCATHETER-URINARY DRAINAGE CATHETER | Marian Medical, Inc. | GBM | Class II | 2007-03-05 |
| K063786 | ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2 | Olympus Medical Systems Corporation | FCX | Class II | 2007-03-05 |
| K061622 | PS SERIES | Photonic Optische Gerate Gesmbh & Cokg | FFS | Class II | 2007-03-05 |
| K060899 | FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE | Schoelly Imaging, Inc. | FAJ | Class II | 2007-03-02 |
| K063847 | FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700 | Fujinon, Inc. | FDS | Class II | 2007-03-01 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.