meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
54
Latest Decision
2011-10-06

Clearances · page 31 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K110531 ENDOFLIP ECD Crospon, Ltd. FED Class II 2011-10-06
K111740 AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION Ameriwater FIP Class II 2011-10-05
K112456 ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT Teleflexmedical, Inc. GCJ Class II 2011-10-04
K112584 5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT Intuitive Surgical, Inc. NAY Class II 2011-09-29
K112434 BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION Bd Medical Surgical KNT Class II 2011-09-29
K103217 LITE-MED LM-9200 ELMA Lite-Med, Inc. LNS Class II 2011-09-28
K112477 PALINDROME H, SI, HSI CHRONIC CATHETER Covidien NYU Class II 2011-09-28
K111845 THE ESPINER SAC OR E SAC Espiner Medical Limited GCJ Class II 2011-09-26
K111174 NXSTAGE PUREFLOW SL Nxstage Medical, Inc. FKR Class II 2011-09-19
K112198 EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE Boston Scientific Corporation ODG Class II 2011-09-14
K112196 OCTOTMPORT Dalim Surgnet Corporation OTJ Class II 2011-09-14
K111622 UNIMAX ANTI-FOG SOLUTION Unimax Medical Systems, Inc. OCT Class II 2011-09-09
K112209 PREFILLED CATHETER INFLATION SYRINGE Avail Medical Products, Inc. KNY Class II 2011-09-08
K111765 FULL CORE BIOPSY SYSTEM Promex Technologies, LLC KNW Class II 2011-09-06
K112349 VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR Covidien, Formerly US Surgical A Divison of Tyco H GCJ Class II 2011-09-01
K111817 PALINDROME RT CHRONIC CATHETER Covidien MSD Class II 2011-08-30
K110451 ENDOWRIST ONE SUCTION/IRRIGATOR Intuitive Surgical, Inc. NAY Class II 2011-08-26
K112137 COMFORTGLIDE INTERMITENT CATHETER C.R. Bard, Inc. EZD Class II 2011-08-26
K093915 DEKA TAC DEVICE Deka Research & Development Corp. FIG Class II 2011-08-23
K111365 VITALA CONTINENCE CONTROL DEVICE Convatec, Inc. EZQ Class I 2011-08-19
K111900 NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER Teleflexmedical, Inc. MSD Class II 2011-08-17
K111760 NAVIAID(TM) BGC DEVICE Smart Medical Systems , Ltd. ODC Class II 2011-08-09
K111047 CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES Mauna Kea Technologies, Inc. OWN Class II 2011-08-08
K111372 TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)... Covidien MSD Class II 2011-08-04
K110005 SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE Syncro Medical Innovations, Inc. KNT Class II 2011-08-04
K110653 CURE CATHETER Cure Medical, LLC EZD Class II 2011-08-01
K111808 SONOLITH I-MOVE Edap Tms France LNS Class II 2011-08-01
K103220 VOYAGER PERITONEAL DIALYSIS SYSTEM Deka Research & Development Corp. FKX Class II 2011-07-29
K111529 MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN- Insert Molding Solutions, Inc. KNW Class II 2011-07-29
K111821 BIOPSY VALVE Endochoice, Inc. OCX Class II 2011-07-28
K103694 TISSUE SAMPLING NEEDLE United States Endoscopy Group, Inc. FCG Class II 2011-07-27
K110529 ENDOFLIP GASTRIC TUBE Crospon, Ltd. KNT Class II 2011-07-22
K111495 COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K Wilson-Cook Medical, Inc. FBK Class II 2011-07-19
K111002 REPROCESSED ENDOSCOPIC TROCARS Sterilmed, Inc. NLM Class II 2011-07-18
K110285 NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER Nephros, Inc. FIP Class II 2011-07-14
K111117 CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC... Teleflexmedical, Inc. MSD Class II 2011-06-30
K110518 IBAG Future Path Medical, LLC KNX Class II 2011-06-24
K102771 BIOPSY HANDY, MRI BIOPSY HANDY Somatex Medical Technologies GmbH KNW Class II 2011-06-24
K103698 TENSCARE ITOUCH SURE MODEL ITS Tenscare, Ltd. KPI Class II 2011-06-21
K110291 NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE Smart Medical Systems , Ltd. ODC Class II 2011-06-17
K110823 PRISMAFLEX Gambro Renal Products, Inc. KDI Class II 2011-06-17
K111100 ENCOR ENSPIRE BREAST BIOPSY SYSTEM C.R. Bard, Inc. KNW Class II 2011-06-16
K102949 COLONOSCOPY ASSISTANT Sti Medical Systems, LLC FET Class II 2011-06-15
K110936 DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT AngioDynamics, Inc. MSD Class II 2011-06-10
K110088 DEFENDO Y-OPSY IRRIGATOR Byrne Medical Incorporated ODC Class II 2011-06-10
K111315 MULTIPURPOSE DRAINAGE CATHETER Navilyst Medical, Inc. FGE Class II 2011-06-08
K110883 J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA Busse Hospital Disposables KNW Class II 2011-06-08
K103086 DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC Dynarex Corporation EZD Class II 2011-06-07
K101733 REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES Sac, LLC Dba Pinnacle Medical Surgical GCJ Class II 2011-06-06
K110829 ACE STAPLER AND CARTRIDGE Barosense, Inc. OCW Class II 2011-06-03
K110214 DIRECTVISION CATHETER, UNCOATED Percuvision EZL Class II 2011-05-27
K092338 MEDAX UNIPERSONALE SRL Medax Unipersonale Srl KNW Class II 2011-05-27
K102466 FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR Fujinon, Inc. FET Class II 2011-05-25
K110792 GELPOINT PATH Applied Medical Resources Corp. FER Class II 2011-05-23
K103832 PHOENIX HEMODIALYSIS DELIVERY SYSTEM Gambro Renal Products, Inc. KDI Class II 2011-05-20
K110578 MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM Mar Cor Purification, Inc. FIP Class II 2011-05-20
K103509 UNIMAX SUCTION IRRIGATION SET Unimax Medical Systems, Inc. GCJ Class II 2011-05-19
K102887 ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510 Percutaneous Systems, Inc. FFL Class II 2011-05-16
K111243 FUJINON ULTRASONIC PROCESSOR Fujinon, Inc. FDS Class II 2011-05-16
K110853 VR MEDICAL ENTERAL ORAL SYRINGE Vr Medical FPD Class II 2011-05-13
K103025 GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES Given Imaging , Ltd. NEZ Class II 2011-05-13
K110122 MUSTANG BALLOON DILATAION CATHETERS Boston Scientific FGE Class II 2011-05-12
K103312 UPD-Y0003 Olympus Medical Systems Corporation FDF Class II 2011-05-12
K110121 WEXLER ENDOSCOPE ACCESSORIES Microsurgical Laboratories,Inc.Dba Wexler Surgical GCJ Class II 2011-05-10
K103611 UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION United States Endoscopy Group, Inc. FDI Class II 2011-05-09
K103510 UNIMAX SPECIMEN RETRIEVAL SYSTEM Unimax Medical Systems, Inc. GCJ Class II 2011-05-06
K101158 LIC INSTRUMENT PROCESSING SYSTEM Langford IC Systems, Inc. FEB Class II 2011-05-06
K110396 ASPIRA PERITONEAL DRAINAGE SYSTEM C.R. Bard, Inc. PNG Class II 2011-05-06
K110257 DIAMOND-FLEX(R) GRASPERS Carefusion 2200, Inc. GCJ Class II 2011-05-06
K110862 VAPRO PLUS INTERMITTENT CATHETER Hollister Incorporated GBM Class II 2011-04-26
K102194 SOLCART B B. Braun Avitum AG KPO Class II 2011-04-25
K110833 CRE BALLOON DILATATION CATHETER Boston Scientific Corporation FDT Class II 2011-04-20
K110887 INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER Boston Scientific Corporation KNS Class II 2011-04-14
K101581 INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000 Intuitive Surgical, Inc. NAY Class II 2011-04-08
K103326 MULTIPLE BIOPSY SYSTEM United States Endoscopy Group, Inc. FCK Class II 2011-04-06
K101482 EM-9000 Elite Medical, Inc. LNS Class II 2011-03-31
K102936 HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R Baxter Healthcare Corp FKX Class II 2011-03-30
K103813 SOPRO 281 Sopro NTN Class II 2011-03-22
K103696 ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES Erbe USA, Inc. FEQ Class II 2011-03-22
K110453 RELIANCE ENDOSCOPE PROCESSING SYSTEM STERIS Corporation NZA Class II 2011-03-16
K110491 BACKSTOP CATHETER Pluromed, Inc. KOD Class II 2011-03-16
K102839 SPIDER STANDARD AND ADVANCED Transenterix, Inc. GCJ Class II 2011-03-15
K103371 COUDE/ OR TIEMANN Degania Silicone , Ltd. EZL Class II 2011-03-11
K101250 GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES Given Imaging , Ltd. NEZ Class II 2011-03-07
K103741 SURGISURE TISSUE REMOVAL SYSTEM Interlace Medical, Inc. GCJ Class II 2011-03-02
K103647 THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES Thd Spa FER Class II 2011-03-01
K103478 SINGLE USE BILIARY DRAINAGE STENT V Olympus Medical Systems Corporation FGE Class II 2011-02-24
K103253 SILS PORT Coviden (Formerly Registered AS US Surgical, A Div GCJ Class II 2011-02-24
K103264 ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO Olympus Medical Systems Corporation FEB Class II 2011-02-23
K103302 STEMPRO MSC SFM Life Technologies Corporation NDS Class II 2011-02-18
K102763 SYSTEMS INTEGRATION Olympus Medical Systems Corporation ODA Class II 2011-02-15
K110157 SYSLOC MINI V3 JMS North America Corporation FIE Class II 2011-02-11
K103242 REDSENSE-ALARM UNIT AND SENSOR Redsense Medical AB ODX Class II 2011-02-10
K103564 VENOFER PUMP Renal Solutions, Inc. KDI Class II 2011-02-10
K100533 VISTA ENDOSCOPE,89 CM, 56CM , SCOUT BLUNT-TIPPED GUIDE- 106 CM, 86 CM, 53 CM, MODELS FG0027, FG0031, FG0029, FG 0028, Vibrynt, Inc. GCJ Class II 2011-02-08
K101900 HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH Hakki Medical Technologies, Inc. GBM Class II 2011-02-07
K101077 DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100 Intuitive Surgical, Inc. GCJ Class II 2011-02-04
K101743 5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319 Intuitive Surgical, Inc. NAY Class II 2011-02-04
K070049 FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR Fresenius Medical Care North America ONW Class II 2011-02-03
K102892 ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS Aqua Sciences, Inc. FIP Class II 2011-02-03

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