meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
54
Latest Decision
2006-06-27

Clearances · page 39 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K061684 MEDI-GLOBE ROTA-CUT SPHINCTEROTOME Medi-Globe Corporation KNS Class II 2006-06-27
K060509 PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING Tyco Healthcare Group NYU Class II 2006-06-23
K061324 EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7 Rtc Inc.-Memcath Technologies, LLC FED Class II 2006-06-20
K060817 OMNILINK. 018 BILIARY STENT SYSTEM Guidant Endovascular Solutions, Inc. FGE Class II 2006-06-15
K052764 DIACAP ULTRA DIALYSIS FLUID FILTER B. Braun Medizintechnologie GmbH FKQ Class II 2006-06-09
K061235 LIFESTENT TURBO BILIARY STENT SYSTEM Edwards Lifesciences, LLC FGE Class II 2006-06-05
K061025 ACCUTECH ENDOLITE PROBE Accutech Medical Technologies, Inc. FFS Class II 2006-05-31
K061201 DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087 United States Endoscopy Group, Inc. FCK Class II 2006-05-30
K053382 LAPARO-THORACO VIDEOSCOPE XLTF-VAW Olympus Medical Systems Corporation GCJ Class II 2006-05-26
K060381 ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100 Renal Solutions, Inc. FKT Class II 2006-05-24
K060805 MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd. NSI Class II 2006-05-24
K053539 MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 Baxter Healthcare Corporation KDI Class II 2006-05-24
K052299 REPROCESSED ENDOSCOPIC TROCAR Sterilmed, Inc. NLM Class II 2006-05-23
K061260 INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214 Intuitive Surgical, Inc. NAY Class II 2006-05-18
K051073 MIDIVIEW SERIES OF MICROENDOSCOPES Millennium Devices, Inc. GCJ Class II 2006-05-17
K061216 USGI TRANSPORT ENDOSCOPIC GUIDE Usgi Medical FED Class II 2006-05-15
K052952 CATHASSIST Physician Technologies, Inc. KNY Class II 2006-05-14
K060155 15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS Spire Biomedical, Inc. MSD Class II 2006-05-09
K053639 GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd. NEZ Class II 2006-05-08
K061068 EG-3670URK Pentax Medical Company ODG Class II 2006-05-03
K061009 PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS Onset Medical Corporation EZN Class II 2006-05-02
K061021 ENTAKE STANDARD AND SAFETY PEG SYSTEM Conmedcorp KNT Class II 2006-04-28
K060877 PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX Cordis Corp. FGE Class II 2006-04-27
K060085 STRYKER SCOPE/INSTRUMENT HOLDER Stryker Endoscopy GCJ Class II 2006-04-27
K060413 INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE Intact Medical Corporation KNW Class II 2006-04-27
K060717 NURSE ASSISTANT 1.7 O.R. CONTROL SYSTEM Conmed Integrated Systems (Cmis) GCJ Class II 2006-04-25
K060195 GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE Gambro Renal Products KDI Class II 2006-04-24
K060166 OHMEGA Medical Measurement Systems B.V. FFX Class II 2006-04-21
K060962 ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100 Byrne Medical, Inc. OCX Class II 2006-04-19
K053589 LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING Bard Access Systems, Inc. MSD Class II 2006-04-13
K060777 SMITH & NEPHEW MODEL 660HD IMAGE MANAGEMENT SYSTEM Smith & Nephew, Inc. GCJ Class II 2006-04-13
K053459 OMNILINK .035 BILIARY STENT SYSTEM Guidant Corporation FGE Class II 2006-04-12
K060302 INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED Cordis Europa, N.V. KNQ Class II 2006-04-11
K060391 INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182 Intuitive Surgical, Inc. NAY Class II 2006-04-10
K060629 GELPORT BLUNT TIP TROCAR SYSTEM Applied Medical Resources Corp. GCJ Class II 2006-04-07
K060296 NXSTAGE DIALYSATE PREPARATION MODULE Nxstage Medical, Inc. FKR Class II 2006-03-31
K060269 ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM Acmi Corporation FBN Class II 2006-03-31
K053123 PD CATH Med-Conduit, Inc. FJS Class II 2006-03-29
K060673 PEDIATRIC URETERAL STENT Applied Medical Resources Corp. FAD Class II 2006-03-29
K060487 LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM Edwards Lifesciences, LLC FGE Class II 2006-03-23
K060475 EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8 Olympus Medical Systems Corporation ODB Class II 2006-03-17
K053560 MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE Vision-Sciences, Inc. FAJ Class II 2006-03-16
K053434 MYOTRAC INFINITI ELECTRICAL STIMULATOR Thought Technology , Ltd. KPI Class II 2006-03-15
K060534 INTUITIVE SURGICAL SEAL Applied Medical Resources Corp. GCJ Class II 2006-03-13
K060023 ANGIODYNAMICS TOTAL ABSCESSION BILIARY DRAINAGE CATHETER AngioDynamics, Inc. FGE Class II 2006-03-09
K060057 PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM Ev3, Inc. FGE Class II 2006-03-08
K053454 RX HERCULINK ELITE BILIARY STENT SYSTEM Guidant Corporation FGE Class II 2006-03-06
K053640 INTEGRA Direx Systems Corp. LNS Class II 2006-03-01
K060034 NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE Nipro Medical Corporation OCY Class II 2006-02-28
K060268 PEDIATRIC URINARY CATHETER Clay Kennard GBM Class II 2006-02-24
K053512 HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310 Baxter Healthcare Corp FKX Class II 2006-02-16
K052168 MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC. Medline Industries, Inc. EZL Class II 2006-02-16
K053429 ADVANCED UROLOGICAL CATHETER Entracare, LLC EZL Class II 2006-02-08
K060008 AQUADEX FLEXFLOW SYSTEM Chf Solutions, Inc. KDI Class II 2006-02-02
K052930 NAVIGATOR ENDOSCOPY SYSTEM Neoguide Systems, Inc. FDF Class II 2006-01-31
K050952 HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR Minntech Corp. KDI Class II 2006-01-31
K053028 TECHDEVICE GUIDEWIRE Techdevice Corporation OCY Class II 2006-01-31
K053311 STRYKER SCOPE WARMER Stryker Endoscopy GCJ Class II 2006-01-27
K060096 MODULAR TROCAR SYSTEM Applied Medical Resources Corp. GCJ Class II 2006-01-24
K060051 SPECIMEN RETRIEVAL SYSTEM Applied Medical Resources Corp. GCJ Class II 2006-01-19
K053169 RM3 RENAL PRESERVATION SYSTEM Waters Instruments, Inc. KDK Class II 2006-01-17
K051031 AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS Ameriwater FIN Class II 2006-01-06
K053322 MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS Roei Medical Technologies, Ltd. FAS Class II 2006-01-06
K053410 GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR Kendall FEG Class II 2006-01-06
K053008 E-Z-EM ENDOSCOPIC CO2 REGULATOR E-Z-Em, Inc. FCX Class II 2005-12-27
K053286 MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION Nxstage Medical, Inc. KPO Class II 2005-12-22
K053404 LIFESTENT FLEXSTART BILIARY STENT SYSTEM Edwards Lifesciences, LLC FGE Class II 2005-12-21
K053245 GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER Uresil, LLC FGE Class II 2005-12-20
K052135 CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER Cybersonics, Inc. FFK Class II 2005-12-20
K052338 SOLAR GI Medical Measurement Systems B.V. FFX Class II 2005-12-15
K051520 GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H Gambro Renal Products KDI Class II 2005-12-09
K052539 COOK FORMULA 418 BILIARY STENT SYSTEM Cook, Inc. FGE Class II 2005-12-09
K053007 SKYLARK URO PROBE Skylark Device & Systems Co., Ltd. KPI Class II 2005-12-05
K052184 GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd. NSI Class II 2005-12-01
K051280 MEDCOMP SPLIT CATH II Medcomp MSD Class II 2005-11-30
K050209 SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM Smith & Nephew, Inc. GCJ Class II 2005-11-23
K053151 RUBICOR MAGIC BREAST BIOPSY DEVICE Rubicor Medical, Inc. KNW Class II 2005-11-18
K051620 MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES Better Water, Inc. FIP Class II 2005-11-18
K052413 TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934 Medtronic Vascular KNS Class II 2005-11-17
K051711 PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS Denver Biomedical, Inc. PNG Class II 2005-11-15
K051886 OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F Olympus Medical Systems Corporation FBN Class II 2005-11-14
K052393 B. BRAUN MODIFIED BICARBONATE DIALYSATE B.Braun Medical, Inc. KPO Class II 2005-11-09
K050609 AQUADEX SYSTEM Chf Solutions, Inc. KDI Class II 2005-11-09
K052903 PEDIATRIC FEEDING TUBE Promedic, Inc. KNT Class II 2005-11-09
K052638 ABBOTT SPINE, INC. SPINNAKER SYSTEM Abbott Spine, Inc. KNW Class II 2005-11-07
K043207 OZONE GENERATOR Ge Infrastructure Water & Process Technologies NII Class II 2005-11-04
K052435 PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS Pneumrx, Inc. KNW Class II 2005-11-03
K051206 Y2K2 ENTERNAL TUBE FLUID FILTER Moss Medical Products KNT Class II 2005-11-02
K052253 MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS Gambro Renal Products KPO Class II 2005-11-02
K052802 MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE Manan Medical Products, Inc. KNW Class II 2005-11-01
K051637 DSNARE, MODEL 00711087 United States Endoscopy Group, Inc. FCK Class II 2005-10-31
K051276 HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM Richard Wolf Medical Instruments Corp. OCZ Class II 2005-10-28
K043383 N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110 Physion, Inc. FBK Class II 2005-10-27
K052740 NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM Conmed Integrated Systems (Cmis) GCJ Class II 2005-10-17
K052025 URGENT PC NEUROMODULATION SYSTEM Uroplasty, Inc. NAM Class II 2005-10-17
K051645 EVIS EXERA 160A SYSTEM Olympus Medical Systems Corporation NWB Class II 2005-10-13
K051480 ENTERAL FEEDING TUBE Biosearch Medical Products, Inc. BSS Class II 2005-10-12
K052440 MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER Mentor Corporation EZD Class II 2005-10-11
K052279 COOK IRELAND ECHOBRUSH Cook Ireland, Ltd. FDX Class II 2005-10-11
K051950 INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321 Ethicon Endo-Surgery, Inc. MND Class II 2005-10-07

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