meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
51
Latest Decision
2011-02-01

Clearances · page 32 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K102238 ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER Teleflexmedical, Inc. MSD Class II 2011-02-01
K103254 PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE Coloplast A/S KNT Class II 2011-01-31
K110004 ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE Advanced Surgical Concepts OTJ Class II 2011-01-26
K103353 MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETER Navilyst Medical, Inc. FGE Class II 2011-01-14
K103688 G-PROX EZ ENDOSCOPIC GRASPER Usgi Medical OCZ Class II 2011-01-14
K103088 GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT Given Imaging , Ltd. NEZ Class II 2011-01-14
K102996 MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR Medivators Reprocessing Systems FEB Class II 2011-01-13
K110030 EXPECT ENDOSCOPIC ASPIRATION NEEDLE Boston Scientific Corp ODG Class II 2011-01-12
K102781 RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS Olympus Winter & Ibe GmbH FAS Class II 2011-01-11
K103349 BACKSTOP CATHETER Pluromed, Inc. KOD Class II 2011-01-07
K103043 COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH Adapta Medical, Inc. EZD Class II 2011-01-07
K101750 RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104 Reprocessing Products Corp MNV Class II 2011-01-07
K102379 LTF-Y0009; MAJ-YOO41; XOEV-3D1 Olympus Medical Systems Corporation GCJ Class II 2011-01-05
K103668 BNX FINE NEEDLE ASPIRATION SYSTEM Boston Endoscopic Engineering FCG Class II 2010-12-30
K102663 AED RESECTOSCOPE National Advanced Endoscopy Devices, Inc. FJL Class II 2010-12-30
K102616 NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE Smart Medical Systems , Ltd. FDF Class II 2010-12-30
K103412 AXIOM FASCIAL CLOSURE SYSTEM Axiom Technology Partners, LLC OCW Class II 2010-12-30
K102931 G-CINCH SUTURE GRASPER Usgi Medical OCW Class II 2010-12-30
K103239 IRRIGATION SYSTEM United States Endoscopy Group, Inc. OCX Class II 2010-12-30
K102572 IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT Sainath Intellectual Properties, LLC KNT Class II 2010-12-27
K103359 FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK) C.R. Bard, Inc. KNW Class II 2010-12-27
K103437 US ENDOSCOPY CYTOLOGY BRUSH United States Endoscopy Group, Inc. FDX Class II 2010-12-23
K102452 DEFOGGING AND CLEANING SOLUTION- FLO-X Minimally Invasive Devices, LLC OCT Class II 2010-12-23
K103235 ERBEFLO 2 DISPOSABLE TUBING SYSTEM Erbe USA, Inc. OCX Class II 2010-12-23
K102391 BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM C.R. Bard, Inc. KNT Class II 2010-12-22
K102605 MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER Covidien, LLC, Formerly Registered AS Tyco Healthca NIE Class II 2010-12-22
K102764 RESOLUTION II CLIP Boston Scientific Corporation PKL Class II 2010-12-22
K103109 PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE C.R. Bard, Inc. KNT Class II 2010-12-22
K100451 GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132 Gambro Renal Products, Inc. MPB Class II 2010-12-21
K101715 FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 Fresenius Medical Care North America, Design Cente KDI Class II 2010-12-21
K102214 ENDO FLIP Crospon, Ltd. FFX Class II 2010-12-16
K100700 MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES Benlan, Inc. FPD Class II 2010-12-13
K093641 TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM Tango3, LLC FIN Class II 2010-12-08
K102244 RELIANCE ENDOSCOPE PROCESSING SYSTEM STERIS Corporation NZA Class II 2010-12-03
K102179 ENVIEW (TM) Carefusion 2200 OCV Class II 2010-12-02
K102543 BRAVO PH MONITORING SYSTEM AND ACCESSORIES Given Imaging , Ltd. FFT Class I 2010-12-01
K101428 OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET Ovesco Endoscopy AG PKL Class II 2010-12-01
K102536 VITALA CONTINENCE CONTROL DEVICE Convatec, Inc. EZQ Class I 2010-12-01
K101794 ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA Advanced Surgical Concepts OTJ Class II 2010-11-29
K102548 FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE Footprint Medical, Inc. KNT Class II 2010-11-26
K102519 FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX Flexible Stenting Solutions, Inc. FGE Class II 2010-11-22
K102855 UNIVERSAL IRRIGATION SOLUTION HYBRID Byrne Medical, Inc. OCX Class II 2010-11-19
K102043 ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER Rex Medical MSD Class II 2010-11-18
K102581 DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305 Byrne Medical, Inc. ODC Class II 2010-11-08
K102527 IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER Boston Scientific Corporation KOD Class II 2010-11-05
K102409 DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 Byrne Medical, Inc. ODC Class II 2010-11-04
K091360 CLEARFLUX DIALYZER REPROCESSING SYSTEM Novaflux Technologies LIF Class II 2010-11-03
K102646 SPIDER FLEX MONOPOLAR HOOK Transenterix, Inc. GCJ Class II 2010-11-03
K100364 GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 Gambro Renal Products, Inc. FJK Class II 2010-11-03
K102801 PHTIP DISPOSABLE ISFET CATHETER E-Cath Co., Ltd. FFX Class II 2010-10-26
K093069 NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE Nxstage Medical, Inc. KDI Class II 2010-10-23
K101847 URGENT PC STIMULATOR; URGENT PC LEAD SET Uroplasty, Inc. NAM Class II 2010-10-21
K101843 DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT AngioDynamics, Inc. MSD Class II 2010-10-20
K092571 GYRUS ACMI BIOCOAG PROBE Gyrus Acmi, Inc. KNS Class II 2010-10-20
K101193 PMC LAPAROSCOPIC INSTRUMENTS Pmc Medical GmbH GCJ Class II 2010-10-18
K102485 RE-TRACE URETERAL ACCESS SHEATH Coloplast A/S FED Class II 2010-10-18
K102059 AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017 Olympus Medical Systems Corporation FET Class II 2010-10-08
K101657 RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40 Boston Scientific Corp KGE Class II 2010-10-05
K093893 SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Idev Technologies, Inc. FGE Class II 2010-10-05
K091989 PERFADEX AND PERFADEX WITH THAM Xvivo Perfusion AB KDN Class II 2010-10-01
K101200 PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE Given Imaging , Ltd. NEZ Class II 2010-09-30
K102219 SOCORRO SMI TUNNEL RELEASE DEVICE Socorro Medical, Inc. GCJ Class II 2010-09-24
K101824 AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER Amsino International, Inc. EZL Class II 2010-09-13
K100899 OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 Keymed (Medical & Industrial Equipment), Ltd. FEQ Class II 2010-09-13
K100442 FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM Surgical Innovations Group Plc GCJ Class II 2010-09-07
K102273 MERIT BIPOLAR COAGULATION PROBE Merit Medical Systems, Inc. KNS Class II 2010-09-07
K101810 3DHJD CAMERA SYSTEM MODEL Vision Systems Group, A Division of Viking Systems GCJ Class II 2010-08-30
K093725 CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C Canada Endoscope Corporation FAJ Class II 2010-08-30
K102169 CYBERWAND LITHOTRIPTER Cybersonics, Inc. FFK Class II 2010-08-30
K101199 GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, Maquet Critical Care AB KNT Class II 2010-08-27
K101832 BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT Medical Device Technologies, Inc. KNW Class II 2010-08-27
K093783 INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORT Innovia, LLC GCJ Class II 2010-08-23
K102082 EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470 Boston Scientific Corp FGE Class II 2010-08-23
K093785 MODULAR ENDOSCOPE Sialo Technology, Ltd. GCJ Class II 2010-08-18
K102167 LO-50 LED LIGHT SOURCE Fiberoptics Technology, Inc. NTN Class II 2010-08-17
K093362 2008 HEMODIALYSIS SORBENT SYSTEM Renal Solutions, Inc. FKT Class II 2010-08-13
K101937 HYBRID TROCAR SYSTEM Aesculap, Inc. GCJ Class II 2010-08-11
K101298 ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS Endochoice, Inc. OCZ Class II 2010-08-05
K100966 COLONOSCOPE/SIGMOIDOSCOPE SHEATHES Sheathing Technologies, Inc. FDF Class II 2010-08-03
K100288 NEOMED ENTERAL ONLY EXTENSION SET Neomed, Inc. KNT Class II 2010-08-03
K093079 TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U Hobbs Medical, Inc. KNS Class II 2010-08-02
K101261 CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 C.R. Bard, Inc. NFK Class II 2010-07-29
K093608 GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H Gambro Renal Products, Inc. FIP Class II 2010-07-29
K101191 NAVIAID ICVI DEVICE Smart Medical Systems , Ltd. FDF Class II 2010-07-27
K101786 ADVANIX DOUBLE PIGTAIL BILIARY STENT Boston Scientific Corp FGE Class II 2010-07-23
K101314 ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM Boston Scientific Corp FGE Class II 2010-07-23
K101214 GUARDIAN CONNECTION Maulin Medical, LLC FPD Class II 2010-07-23
K101101 MINI-TONG Mini Lap Technologies, Inc. OCW Class II 2010-07-23
K101095 DIRECT PERORAL CHOLANGIOSCOPY BALLOON Wilson-Cook Medical, Inc. FGE Class II 2010-07-19
K101146 WATER BOTTLE CAP SYSTEM United States Endoscopy Group, Inc. FEQ Class II 2010-07-16
K100109 LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE Surgical Innovations Plc GCJ Class II 2010-07-15
K093497 THD BANDY Thd Spa FHN Class II 2010-07-15
K101053 OLYMPUS CF TYPE Y0023-L, Y0023I Olympus Medical Systems Corporation FDF Class II 2010-07-14
K093964 VENOFER PUMP Renal Solutions, Inc. KDI Class II 2010-07-09
K100584 EVIS EXERAII 180 SYSTEM Olympus Medical Systems Corporation NWB Class II 2010-07-02
K100302 MEDLINE PVC URETHRAL CATHETER Medline Industries, Inc. EZD Class II 2010-07-02
K100275 WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS Olympus Winter & Ibe GmbH FAS Class II 2010-07-01
K100045 OCTO Dalim Surgnet Corporation GCJ Class II 2010-06-25
K101671 SINGLE SITE FLEXIBLE BLADELESS OBTURATOR Teleflexmedical, Inc. GCJ Class II 2010-06-25
K082102 GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 Apollo Endosurgery, Inc. FED Class II 2010-06-14

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