meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
56
Latest Decision
2014-04-04

Clearances · page 27 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K140315 US ENDOSCOPY DISTAL ATTACHMENT CAP United States Endoscopy Group, Inc. OCX Class II 2014-04-04
K133470 BARD RITECATH INTERMITTENT CATHETER C.R. Bard, Inc. EZD Class II 2014-04-04
K131202 MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X Dialysis Medical Solutions, LLC KPO Class II 2014-04-03
K133933 INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER Boston Scientific Corporation KNS Class II 2014-04-02
K131861 DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES Intuitive Surgical, Inc. NAY Class II 2014-03-28
K133599 CORGRIP Corpak Medsystems KNT Class II 2014-03-26
K133807 MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT Gambro Renal Products, Inc. FLD Class II 2014-03-26
K140137 SAFETY BIOPSY NEEDLE SYSTEM Pfm Medical, Inc. FCG Class II 2014-03-25
K133734 SEAL SINGLE-USE BIOPSY VALVE Endochoice, Inc. OCX Class II 2014-03-19
K132151 SRS ENDOSCOPIC STAPLING SYSTEM Medigus , Ltd. ODE Class II 2014-03-19
K140405 TORRENT IRRIGATION SYSTEM United States Endoscopy Group, Inc. OCX Class II 2014-03-12
K130981 FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM Cordis Corp. FGE Class II 2014-03-12
K140323 NAVIGATOR HD URETERAL ACCESS SHEATH SETS Boston Scientific FED Class II 2014-03-07
K134026 ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT Olympus Medical Systems Corp. PGU Class II 2014-03-07
K140099 LIGHTHOUSE URINARY CATHETER Seedings Life Science Ventures, LLC EZL Class II 2014-03-04
K133547 NXSTAGE SYSTEM ONE WITH NXVIEW Nxstage Medical, Inc. KDI Class II 2014-03-03
K133702 PRESTO BREAST BIOPSY DEVICE Sontina Medical, LLC KNW Class II 2014-02-28
K131598 ANAL RECTAL OVERTUBE United States Endoscopy Group, Inc. FED Class II 2014-02-26
K134020 INTONEMV Incontrol Medical, LLC KPI Class II 2014-02-25
K132389 CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED Daniel & Daniel Consulting OWN Class II 2014-02-25
K132344 E-Z CHECK OZONE TEST STRIPS Reprocessing Products Corporation (Rpc) MSY Class II 2014-02-25
K133615 WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER Well Lead Medical Co., Ltd. EZD Class II 2014-02-24
K133948 BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT Bard Peripheral Vascular, Inc. KNW Class II 2014-02-21
K131426 MEDLINE BIOPSY VALVE Medline Industries, Inc. OCX Class II 2014-02-21
K133432 SHERPA PAK CARDIAC TRANSPORT SYSTEM Paragonix Technologies, Inc. MSB Class II 2014-02-21
K133076 NOVAGOLD HIGH PERFORMANCE GUIDEWIRE Neometrics, Inc. OCY Class II 2014-02-20
K133845 8MM TROCAR KIT Intuitive Surgical GCJ Class II 2014-02-19
K132192 BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR Bracco Diagnostic, Inc. FCX Class II 2014-02-14
K131260 NMI DIALYSIS CATHETER Navilyst Medical, Inc. MSD Class II 2014-02-14
K132424 METRIXCARE The Metrix Company KNT Class II 2014-02-12
K133359 ENDORINGS Endo-Aid, Inc. FED Class II 2014-02-11
K130511 CITRISOL ACID CONCENTRATE Diasol, Inc. KPO Class II 2014-02-10
K130616 MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES Biopsybell S.R.L. KNW Class II 2014-02-07
K132839 FUSE 1C COLONOSCOPY SYSTEM Endochoice, Inc. FDF Class II 2014-02-06
K132602 STREAMLINE EXPRESS Nxstage Medical, Inc. KDI Class II 2014-02-04
K133796 NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM), Marvao Medical Devices, Ltd. MSD Class II 2014-01-31
DEN120023 GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM Given Imaging , Ltd. PGD Class II 2014-01-29
K133881 MACY CATHETER Hospi Corporation KNT Class II 2014-01-24
K133987 CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES Boston Scientific Corporation FDI Class II 2014-01-24
K133414 REPROCESSED CLOSURE SYSTEM Sterilmed, Inc. NLM Class II 2014-01-22
K132065 INJECTION NEEDLE Endochoice, Inc. FBK Class II 2014-01-17
K133375 BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR Banyan Medical, LLC GCJ Class II 2014-01-17
K132890 SUPRAPUBIC CATHETER AND INTRODUCER SET Mediplus , Ltd. KOB Class II 2014-01-17
K130674 ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE Xeridiem Medical Devices KNT Class II 2014-01-13
K132210 FUJIFILM 600 SERIES ENDOSCOPES Fujifilm Medical Systems U.S.A, Inc. FDF Class II 2014-01-10
K130851 CASCADE HEMODIALYSIS/APHERESIS CATHETER Health Line International Corporation MSD Class II 2014-01-09
K133747 ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM Endochoice, Inc. FEQ Class II 2014-01-08
K133750 OCCLUDER OCCLUSION BALLOON CATHETER Boston Scientific Corporation EYB Class II 2014-01-08
K133736 ENDOSCOPIC SUTURE CUTTER United States Endoscopy Group, Inc. OCZ Class II 2014-01-07
K123262 OPTIFLUX ULTRA DIALYZER Fresenius Medical Care North America KDI Class II 2014-01-06
K133826 INTONEMV Incontrol Medical, LLC KPI Class II 2014-01-06
K133312 EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE Boston Scientific Corporation ODG Class II 2014-01-03
K131516 PRISMAFLEX SYSTEM 7.10 Gambro Renal Products, Inc. KDI Class II 2014-01-03
K131364 FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE KARL STORZ Endoscopy-America, Inc. FBO Class II 2014-01-02
K133393 GELPOINT PATH TRANSANAL ACCESS PLATFORM Applied Medical Resources Corp. FER Class II 2014-01-02
K132629 REPROCESSED DILATING TIP TROCARS Stryker Sustainability Solutions NLM Class II 2013-12-31
K131050 NXSTAGE 1.6M2 DIALYZER Nxstage Medical, Inc. KDI Class II 2013-12-27
K132500 CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED Cure Medical, LLC EZD Class II 2013-12-23
K131953 IMAGE1 SPIES KARL STORZ Endoscopy-America, Inc. FET Class II 2013-12-20
K133281 NEOTRACT UROLIFT SYSTEM Neotract, Inc. PEW Class II 2013-12-20
K132776 SEAL BIOPSY VALVE - REUSABLE Endochoice, Inc. OCX Class II 2013-12-20
K131935 ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER Nipro Medical Corporation KDI Class II 2013-12-20
K133513 MULTI-STAGE SNARE United States Endoscopy Group, Inc. FDI Class II 2013-12-20
K131381 ELISIO-H HEMODIALYZER Nipro Medical Corporation KDI Class II 2013-12-19
K130579 PHYSOFT AMS Physicians Software Systems, LLC MQS Class II 2013-12-19
K130611 ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE Xeridiem Medical Devices KNT Class II 2013-12-19
DEN130007 AXIOS STENT AND DELIVERY SYSTEM Xlumena, Inc. PCU Class II 2013-12-18
K132340 ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1 Erbe USA, Inc. FEQ Class II 2013-12-17
K131060 CLEARGUARD HD END CAP Pursuit Vascular, Inc. PEH Class II 2013-12-16
K132785 STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITY Stryker Endoscopy GCJ Class II 2013-12-16
K123728 RETRIEVAL BAG Flexbar Machine Corp. GCJ Class II 2013-12-11
K133687 THD N-ANO ANOSCOPE Thd Spa FER Class II 2013-12-11
K122952 NIPRO PUREFLUX-L HEMODIALYZER Nipro Medical Corporation FJI Class II 2013-12-04
K132232 MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM Minilap Technologies OCW Class II 2013-12-04
K131369 FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM KARL STORZ Endoscopy-America, Inc. FGB Class II 2013-11-26
K132795 CYBERWAND STERILE PROBE SET Cybersonics, Inc. FFK Class II 2013-11-26
K130554 REDSENSE ALARM SYSTEM Redsense Medical AB ODX Class II 2013-11-22
K133008 BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED, Beacon Endoscopic FCG Class II 2013-11-20
K130368 AUTOLITH TOUCH; URO TOUCH Northgate Technologies, Inc. FFK Class II 2013-11-15
K131904 MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA Ameriwater FIP Class II 2013-11-13
K132561 NURO NEUROMODULATION SYSTEM Advanced Uro-Solutions, Inc. NAM Class II 2013-11-05
K131655 LIGHTHOUSE(TM) URINARY CATHETER Seedings Life Science Ventures, LLC EZL Class II 2013-11-04
K131700 SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES Boston Scientific Corp FDI Class II 2013-11-04
K132809 INSTINCT ENDOSCOPIC HEMOCLIP Wilson-Cook Medical, Inc. PKL Class II 2013-10-25
K131590 INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE Philips Medical Systems FPD Class II 2013-10-23
K131157 RANFAC BONE MARROW ASPIRATION NEEDLE Ranfac, Corp. KNW Class II 2013-10-22
K132181 GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER Olympus Surgical Technologies America EZN Class II 2013-10-21
K131991 ENDOCHOICE HOT BIOPSY FORCEPS Endochoice, Inc. KGE Class II 2013-10-15
K131908 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC) Fresenius Medical Care Renal Therapies Group, LLC KDI Class II 2013-10-11
K132619 CLASSIC INTERMITTENT CATHETER Flexicare Medical, Ltd. EZD Class II 2013-10-11
K131422 PEERSCOPE SYSTEM Endochoice, Inc. FDS Class II 2013-10-10
K131739 NXSTAGE CONNECTED HEALTH SYSTEM Nxstage Medical, Inc. FKP Class II 2013-10-10
K132362 WECK EFX ENDO FASCIAL CLOSURE SYSTEM Teleflexmedical, Inc. OCW Class II 2013-10-08
K132337 ESOFLIP BALLOON DILATION CATHETER Crospon, Ltd. PID Class II 2013-10-07
K131201 ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET Cook, Inc. FGE Class II 2013-10-07
K131583 THERMOCHEM HT-2000 Thermasolutions, Inc. MLW Class II 2013-10-03
K130908 DISPOSABLE SILICONE FOLEY CATHETER Guangdong Baihe Medical Technology Co., Ltd. EZL Class II 2013-10-03
K132672 EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER Dornier Medtech America LNS Class II 2013-09-23
K131622 MROZ REVERSE OSMOSIS SYSTEM Ameriwater FIP Class II 2013-09-20
K131375 AUTOLAP SYSTEM Mst - Medical Surgery Technologies , Ltd. GCJ Class II 2013-09-19

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