meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
54
Latest Decision
2010-06-14

Clearances · page 33 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K100366 MEDICINA ENTERAL FEEDING TUBES AND ACCESSORIES MODEL MGX/YY Maxter Catheters KNT Class II 2010-06-14
K100099 ORAL/ENTERAL SYRINGES Philips Children'S Medical Ventures FPD Class II 2010-06-14
K094022 THE WATER LILY Clearwater Products, LLC KPL Class II 2010-06-11
K093902 MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573 Fresenius Medical Care North America KDI Class II 2010-05-27
K100878 SELF CATH CATHETER Coloplast Manufacturing Us, LLC EZD Class II 2010-05-26
K101139 PROSTIVA RF THERAPY MODEL 8929 HAND PIECE Medtronic, Inc. KNS Class II 2010-05-21
K100365 FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV Corpak Medsystems KNT Class II 2010-05-20
K092628 ENTERAL FEEDING TUBE AND ACCESSORIES, FEEDING TUBE EXTENSION SET Alan Reid KNT Class II 2010-05-20
K100616 KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 Life Technologies Corporation NDS Class II 2010-05-20
K093479 DISPOSABLE SUCTION AND IRRIGATION SYSTEM Modern Medical Equipment Mfg., Ltd. FHF Class II 2010-05-19
K101094 CLEARJET Easyglide , Ltd. ODC Class II 2010-05-17
K092789 VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM Terumo Cardiovascular Systems Corp. GCJ Class II 2010-05-12
K082044 ACE STAPLER, MODEL F0031 Barosense, Inc. OCW Class II 2010-05-11
K092955 REDSENSE-HOME USE Redsense Medical AB ODX Class II 2010-05-10
K100852 STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000 Stryker Communications OCS Class II 2010-05-06
K100180 SURGIQUEST ANCHORPORT SIL KIT Surgiquest, Inc. GCJ Class II 2010-05-05
K092033 VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR Elmed USA FFK Class II 2010-04-30
K093899 MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING Ethicon Endo-Surgery, LLC KNW Class II 2010-04-29
K100548 VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP Covidien Lp, Formerly Registered AS Tyco Healthcar GCJ Class II 2010-04-26
K100237 DIALYSATE METER, MODEL D-6 Myron L Company FLB Class II 2010-04-23
K100334 DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 B. Braun Avitum AG KDI Class II 2010-04-22
K100526 AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE Kentec Medical, Inc. FPD Class II 2010-04-22
K100959 SPECIMEN RETRIEVAL SYSTEM Applied Medical Resources GCJ Class II 2010-04-22
K100803 OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 Keymed, Inc. FEQ Class II 2010-04-22
K100273 INSTAFLO BOWEL CATHETER SYSTEM KIT Hollister, Inc. KNT Class II 2010-04-22
K100195 NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X Nds Surgical Imaging GCJ Class II 2010-04-21
K100173 IYUNNI 3ID TRI-FUNNEL FEEDING TUBE KIT Sainath Intellectual Properties, LLC KNT Class II 2010-04-16
K100081 ENTEROSCOPY OVERTUBE, MODEL 00712140 United States Endoscopy Group, Inc. FED Class II 2010-04-12
K093279 NAVIX ACCESS DEVICE Xlumena GCJ Class II 2010-04-07
K092387 MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM Minntech Corp. FEB Class II 2010-04-05
K092481 HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2 New Aqua, LLC (Dba Aqua Systems) FIP Class II 2010-04-02
K083785 VITALA CONTINENCE CONTROL DEVICE Convatec EZQ Class I 2010-04-02
K100712 RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE Boston Scientific Corporation FCG Class II 2010-03-30
K091978 DBB-06 HEMODIALYSIS DELIVERY SYSTEM NIKKISO CO., LTD. KDI Class II 2010-03-25
K093896 ETHICON ENDO SURGERY SLOTTED ANOSCOPE Ethicon Endo-Surgery, Inc. FER Class II 2010-03-25
K093003 BONASTENT BILIARY Endochoice, Inc. FGE Class II 2010-03-24
K092584 LAPORT Mgb Endoskopische Gerate GmbH (Berlin) GCJ Class II 2010-03-22
K100345 SYSTEMS INTEGRATION MODEL: ENDOALPHA Olympus Medical Systems Corporation ODA Class II 2010-03-22
K100080 REPROCESSED TROCARS, MODEL B5LT AND CB5LT Ascent Healthcare Solutions NLM Class II 2010-03-19
K093792 LED LIGHT SOURCE Sunoptic Technologies, LLC FCW Class II 2010-03-18
K100520 NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER Nipro Medical Corporation FIE Class II 2010-03-17
K092352 SCUBA BILIARY STENT SYSTEM Invatec S.P.A. FGE Class II 2010-03-16
K091656 SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L Organ Recovery Systems, Inc. KDL Class II 2010-03-11
K100346 ENDOCLEAR SYSTEM Virtual Ports, Ltd. GCJ Class II 2010-03-10
K093507 OLYMPUS CHF TYPE Y0003 Olympus Medical Systems Corporation FBN Class II 2010-03-10
K093779 CLEARPATH UGI Easyglide , Ltd. FDS Class II 2010-03-09
K093624 OPTISCAN MODEL OPTISCAN CEIS Optiscan Pty. , Ltd. GCJ Class II 2010-03-05
K093194 MGB DISPOSABLE RETRIEVAL BAG LAPBAG Mgb Endoskopische Gerate GmbH (Berlin) GCJ Class II 2010-03-03
K093796 ASEPT PERITONEAL DRAINAGE SYSTEM Pfm Medical, Inc. PNG Class II 2010-02-26
K093181 GYRUS ACMI PK BUTTON ELECTRODE Gyrus Acmi, Inc. FAS Class II 2010-02-24
K093653 URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK Uresil, LLC KNT Class II 2010-02-23
K093718 ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003 Zutron Medical, LLC FCY Class I 2010-02-22
K100169 DURASPAN HEMODIALYSIS LONG-TERM CATHETER R4 Vascular, Inc. MSD Class II 2010-02-18
K083460 DIALOG WITH ADIMEA OPTION B. Braun Avitum AG KDI Class II 2010-02-18
K093120 XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENIUM XPM 170 Baxter Healthcare Corporation - Renal Division KDI Class II 2010-02-17
K093329 SCOPE INTRODUCER MODEL 7400 N.M. Beale Co., Inc. ODC Class II 2010-02-16
K093449 MINI LAP RETRACTORS Mini Lap Technologies, Inc. GCJ Class II 2010-02-12
K093106 ENDOSCOPE REPROCESSOR OER-PRO Olympus Medical Systems Corporation FEB Class II 2010-02-12
K093379 TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM Bl Healthcare, Inc. KDI Class II 2010-02-09
K093637 JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300 Jms North America Corp. FIE Class II 2010-02-09
K092821 TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021 Agency For Medical Innovations, Inc. GCJ Class II 2010-02-01
K093125 ALPHAXENON LIGHT 180 W AND 300 W Gimmi GmbH GCT Class II 2010-01-27
K093985 NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE Nipro Medical Corp. FIE Class II 2010-01-22
K092684 LAPAROSCOPIC RETRACTORS Cardinal Health, Inc. GCJ Class II 2010-01-22
K092250 MEDLINE RED RUBBER URETHRAL CATHETER Medline Industries, Inc. EYB Class II 2010-01-21
K093217 5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM) Intuitive Surgical, Inc. NAY Class II 2010-01-21
K093947 ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC Merit Medical Systems, Inc. FGE Class II 2010-01-21
K093195 ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O Cook Ireland, Ltd. FCG Class II 2010-01-21
K082805 PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX Q Urological Corporation FAD Class II 2010-01-20
K091511 MODERN MEDICAL RESECTOSCOPE ELECTRODES Modern Medical Equipment Mfg., Ltd. FAS Class II 2010-01-15
K092739 MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE C-Link Micro Imaging, Inc. ODF Class II 2010-01-12
K091506 DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520 R4 Vascular, Inc. MSD Class II 2010-01-08
K093392 MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS Navilyst Medical, Inc. FGE Class II 2009-12-31
K093037 PENTEX EC-3890LI Pentax Medical Company FDF Class II 2009-12-28
K093616 V. MUELLER CAMERA CONTROLLER WITH STORAGE CART Carefusion 2200 OCV Class II 2009-12-23
K090993 INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000 Intuitive Surgical, Inc. NAY Class II 2009-12-16
K093665 ENDO SMARTCAP Byrne Medical, Inc. FAJ Class II 2009-12-15
K092850 ENDOFLIP Crospon, Ltd. FFX Class II 2009-12-15
K093312 KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM Kimberly-Clark Corp. KGC Class II 2009-12-08
K093600 OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM Accelerated Care Plus KPI Class II 2009-12-04
K093372 SILS PORT MODEL SILSPT15 Covidien Lp, Formerly Registered AS Tyco Healthcar GCJ Class II 2009-12-03
K092710 PENTAX ED-3490TK, VIDEO DUODENOSCOPE Pentax Medical Company FDT Class II 2009-12-02
K092829 INSERTEASE Christcot Medical Company OOW Class I 2009-12-02
K092090 ERBELIFT HAND PUMP AND FLEXIBLE PROBE Byrne Medical, Inc. FBK Class II 2009-11-30
K090796 MULTI-BITE HOT BIOPSY FORCEPS Endo-Therapeutics, Inc. KGE Class II 2009-11-25
K083770 COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM Coloplast A/S KNT Class II 2009-11-23
K093512 ENCOR BREAST BIOPSY SYSTEM Senorx, Inc. KNW Class II 2009-11-20
K090682 EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00 Edwards Lifesciences Services GmbH KDI Class II 2009-11-19
K093399 PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520 Inrad KNW Class II 2009-11-19
K092429 ENDOGATOR Byrne Medical, Inc. FEQ Class II 2009-11-19
K092797 ACUTE AND CHRONIC CATHETER REPAIR KIT Kendall NFK Class II 2009-11-19
K093256 SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018 Inrad KNW Class II 2009-11-17
K092597 CENTROS CHRONIC HEMODIALYSIS CATHETER SET Ash Access Technology, Inc. MSD Class II 2009-11-12
K093068 FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105US C.R. Bard, Inc. KNW Class II 2009-11-10
K093236 ETHICON ENDO-SURGERYOPTICAL DILATOR Ethicon Endo-Surgery, Inc. KNQ Class II 2009-11-10
K092400 ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5 Endogastric Solutions, Inc. ODE Class II 2009-11-06
K092461 IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140 United States Endoscopy Group, Inc. OCX Class II 2009-11-05
K092504 SURGIQUEST AIRSEAL OPTICAL TROCAR AND CANNULA SYSTEM Surgiquest, Inc. GCJ Class II 2009-11-05
K093187 MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM Avantis Medical Systems, Inc. FDF Class II 2009-11-05
K092359 ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A Cook Ireland, Ltd. FCG Class II 2009-11-02

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