meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
42
Latest Decision
2001-12-03

Clearances · page 48 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K012968 APPLIED ACCESS SEAL Applied Medical Resources Corp. GCJ Class II 2001-12-03
K012115 SERIM BLOOD LEAK TEST STRIP-2 Serim Research Corp. FJD Class II 2001-11-30
K010607 MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 Benlan, Inc. LJH Class II 2001-11-28
K010366 DISPOSABLE STORAGE CAP Molded Products, Inc. FJI Class II 2001-11-28
K011909 ULTRA-THIN SDS BALLOON DILATATION CATHETER Boston Scientific Corp FGE Class II 2001-11-28
K013550 CLIRANS E-SERIES DIALYZER Terumo Medical Corp. KDI Class II 2001-11-20
K012929 FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735 Circon Video FAJ Class II 2001-11-19
K013709 HILL-ROM PRIMAVIEW MONITOR SYSTEM Hill-Rom, Inc. FET Class II 2001-11-16
K010601 FANELLI BILIARY STENT Cook, Inc. FGE Class II 2001-11-16
K012785 TWINTRODE ELC 134 ELECTRODE Healthtronics Surgical Services, Inc. LNS Class II 2001-11-16
K012833 INTUITIVE SURGICAL BIPOLAR FORCEPS Intuitive Surgical, Inc. NAY Class II 2001-11-16
K012752 WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE Boston Scientific Corp FGE Class II 2001-11-15
K012771 TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX Pajunk GmbH GCJ Class II 2001-11-14
K012662 SE-100 VACUUM ERECTION DEVICE Vts, Inc. LKY Class II 2001-11-09
K012639 SE-300 VACUUM THERAPY SYSTEM Vts, Inc. LKY Class II 2001-11-09
K012670 BOSS 2000-3 VACUUM ERECTION DEVICE Pos-T-Vac, Inc. LKY Class II 2001-11-09
K012672 BOSS-2000-2 VACUUM ERECTION DEVICE Pos-T-Vac, Inc. LKY Class II 2001-11-09
K012951 APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE Circon Video FGB Class II 2001-11-09
K012619 VT-1 Vts, Inc. LKY Class II 2001-11-09
K012620 SE-200 Vts, Inc. LKY Class II 2001-11-09
K012724 SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273 Smith & Nephew, Inc. LYK Class II 2001-11-08
K012925 DUR-8, MODELS DUR-8 Circon Video FGB Class II 2001-11-07
K012578 REPROCESSED ENDOSCOPIC TROCAR Sterilmed, Inc. NLM Class II 2001-11-07
K012147 DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE Zevex, Inc. KNT Class II 2001-11-02
K012977 VARICES INJECTION NEEDLE Endo-Therapeutics, Inc. FBK Class II 2001-11-02
K012527 KSEA SIALOENDOSCOPES AND ACCESSORIES KARL STORZ Endoscopy-America, Inc. GCJ Class II 2001-11-01
K003957 DIACLEAR ULTRAFILTER Gambro Renal Products FIP Class II 2001-11-01
K011221 PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET Gambro Renal Products KDI Class II 2001-10-31
K011916 SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES Horizon Medical Products, Inc. MSD Class II 2001-10-31
K012822 MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX Boston Scientific Scimed, Inc. FGE Class II 2001-10-24
K012864 INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836 Boston Scientific Corp FCG Class II 2001-10-24
K013162 14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH Medcomp KNT Class II 2001-10-19
K013356 WILSON-COOK ULTRASOUND BIOPSY NEEDLE Wilson-Cook Medical, Inc. FCG Class II 2001-10-19
K013154 MARK II/MARK III MANOMETRIC PERFUSION PUMP Dentsleeve Pty., Ltd. FFX Class II 2001-10-19
K012309 RIWO SYSTEM TRAYS Richard Wolf Medical Instruments Corp. FEB Class II 2001-10-19
K013153 AUTOTOME RX MODEL # 4515, 4516 Boston Scientific Corp KNS Class II 2001-10-19
K013144 DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE; DUAL PORT WIZARD FEEDING/DECOMPRESSION TUBE, MODEL 00220W C.R. Bard, Inc. KNT Class II 2001-10-19
K012510 MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM Nxstage Medical, Inc. KDI Class II 2001-10-19
K012265 METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 Circon Video FCW Class II 2001-10-17
K012482 STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION KARL STORZ Endoscopy-America, Inc. LNS Class II 2001-10-16
K002512 TORAYSULFONE DIALYZER Toray Industries (America), Inc. KDI Class II 2001-10-15
K012358 CHIBA NEEDLE Ispg, Inc. FCG Class II 2001-10-15
K011080 BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM Medtronic Ave, Inc. FGE Class II 2001-10-11
K010985 GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L Gambro Renal Products KDI Class II 2001-10-10
K012993 MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. FGE Class II 2001-10-05
K003431 ZEUS ROBOTIC SURGICAL SYSTEM Computer Motion, Inc. GCJ Class II 2001-10-05
K003661 SOCRATES ROBOTIC TELEMONITORING SYSTEM Computer Motion, Inc. NEQ Class II 2001-10-05
K012235 DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER Denver Biomedical, Inc. KPM Class II 2001-10-04
K010306 MEDCOMP EXCELL SPLIT TIP CATHETER Medcomp MSD Class II 2001-10-03
K012948 MODIFICATION TO VAXCEL DIALYSIS CATHETER Boston Scientific/Medi-Tech MSD Class II 2001-10-03
K994105 HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 Medical Components, Inc. MSD Class II 2001-10-03
K010592 AQUA WATER TREATMENT FOR HEMODIALYSIS Aqua Water Treatment, Inc. FIP Class II 2001-09-28
K011800 VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS Vanguard Medical Concepts, Inc. NLU Class II 2001-09-27
K010712 DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES Molded Products, Inc. FID Class II 2001-09-27
K012074 XBO1-824-18/19/20 BIOPSY FORCEPS The Olympus Optical Co. OCZ Class II 2001-09-25
K011341 LH400 YES-SET Y-PORT ENTERAL SPIKE PUMP SET Lh Medical Products, Inc. KNT Class II 2001-09-21
K011343 LH 500 ENTERAL FEEDING GRAVITY BAG SET Lh Medical Products, Inc. KNT Class II 2001-09-21
K011340 LH 450 ENTERAL FEEDING BAG PUMP SET W/INTEGRATED Y-PORT Lh Medical Products, Inc. KNT Class II 2001-09-21
K012150 PATTON ENDO-BAG Patton Medical Corp. GCJ Class II 2001-09-20
K012153 LOWSLEY SUPRAPUBIC TRACTOR Circon Video KOB Class II 2001-09-19
K011944 DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088 Smith & Nephew, Inc. GCJ Class II 2001-09-19
K011911 SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX Richard Wolf Medical Instruments Corp. FFK Class II 2001-09-17
K012023 ANCHOR GUIDE LESION LOCALIZATION DEVICE; ANCOR GUIDE HOLDER; RF GENERATOR CABLE Senorx, Inc. KNW Class II 2001-09-12
K011848 CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE Circon Video FFK Class II 2001-09-11
K000031 AQUANET, MODEL EC 2000 Prime Pacific Health Innovations Corporation KPL Class II 2001-09-10
K011841 KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR Karl Storz Endoscopy GCJ Class II 2001-09-10
K012590 CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEM Cordis Corp. FGE Class II 2001-09-07
K011806 PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY Sulzer Intratherapeutics, Inc. FGE Class II 2001-09-07
K002352 JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE Jms Co., Ltd. FIE Class II 2001-09-06
K003988 UROSCOPE, ARTES MEDICAL, USA Artes Medical USA, Inc. FAJ Class II 2001-09-06
K010450 LIVER TAMPONADE BALLOON Cook, Inc. NGU Class II 2001-09-06
K012539 VERASTEP United States Surgical, A Division of Tyco Healthc GCJ Class II 2001-09-06
K011873 DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP) Dornier LNS Class II 2001-08-31
K012476 MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-2010 Applied Medical Technology, Inc. KNT Class II 2001-08-31
K011886 OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160, Olympus America, Inc. ODG Class II 2001-08-27
K010411 PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM Cordis Corp. FGE Class II 2001-08-27
K012445 EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) Electro Medical Systems SA FFK Class II 2001-08-24
K012365 VAXCEL DIALYSIS CATHETER Boston Scientific Corp MSD Class II 2001-08-24
K012374 MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER Astra Tech, Inc. GBM Class II 2001-08-23
K011759 RADIUS NEXT GENERATION GUIDEWIRE Radius Medical Technologies, Inc. OCY Class II 2001-08-23
K012347 PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY Sulzer Intratherapeutics, Inc. FGE Class II 2001-08-23
K012224 SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW Ranfac, Corp. KNW Class II 2001-08-22
K011817 BRIDGE FX Medtronic Ave, Inc. FGE Class II 2001-08-22
K010735 SPEEDYBELL Biopsybell S.A.S. KNW Class II 2001-08-17
K011575 22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022 Imagyn Surgical KNW Class II 2001-08-17
K012216 NIROYAL BILIARY PREMOUNTED STENT SYSTEM Boston Scientific Scimed, Inc. FGE Class II 2001-08-17
K011667 HORIZONS INTERNATIONAL POLYPECTOMY SNARES Horizons Intl. Corp. FDI Class II 2001-08-16
K012242 FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS Fresenius Medical Care North America FJK Class II 2001-08-16
K010754 NURSE'S ASSISTANT O.R. CONTROL SYSTEM Valmed Corp. GCJ Class II 2001-08-15
K010399 DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM) Diatek, Inc. MSD Class II 2001-08-14
K011184 INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS Intratherapeutics, Inc. FGE Class II 2001-08-13
K010242 COOK ZILVER BILIARY STENT Cook, Inc. FGE Class II 2001-08-13
K011472 POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID Medtronic Functional Diagnostics A/S FFX Class II 2001-08-10
K011484 OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 Olympus Optical Co., Ltd. FBK Class II 2001-08-10
K011467 ROSS EMBRACE PUMP SET Ross Products KNT Class II 2001-08-10
K011496 CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660 Richard Wolf Medical Instruments Corp. FBO Class II 2001-08-10
K012198 GIBBONS STERILE TROCAR KITS Gibbons Surgical Corp. FBQ Class II 2001-08-09
K011538 ENDOPATH NON-BLADED SOLID OBTURATOR TROCAR SYSTEM Ethicon Endo-Surgery, Inc. GCJ Class II 2001-08-09
K011368 DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS Gambro Renal Products KPO Class II 2001-08-02
K012056 CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM Cordis Europa, N.V. FGE Class II 2001-08-01

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