meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
50
Latest Decision
2015-04-27

Clearances · page 25 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K150286 Medline Enteral Feeding Sets Medline Industries, Inc. PIF Class II 2015-04-27
K141643 YARLAP International Trade Group, Inc. KPI Class II 2015-04-24
K142506 TensCare KegelFit Tenscare, Ltd. KPI Class II 2015-04-20
K150083 Sidecar External Working Channel C2 Therapeutics FED Class II 2015-04-14
K150705 FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic Cannula, FloShield 10mm Conical Blunt Obturator Minimally Invasive Devices, Inc. GCJ Class II 2015-04-13
K150183 ApexM Incontrol Medical, LLC KPI Class II 2015-04-09
K143344 NeoMed NeoConnect Enteral Syringes with ENFit Connector Neomed, Inc. PNR Class II 2015-04-09
K150010 Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port Cedic S.R.L. PIO Class II 2015-04-02
K143018 Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors Covidien PIF Class II 2015-04-02
K143132 IS4000 8mm Harmonic ACE Curved Shears Intuitive Surgical, Inc. NAY Class II 2015-04-02
K141997 CRIT-LINE IV SYSTEM Fresenius Medical Care KOC Class II 2015-04-01
K150253 Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm Taiwan Surgical Corporation GCJ Class II 2015-04-01
K141991 SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP Olympus Medical Systems Copr. KNS Class II 2015-03-31
K143567 NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (36cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (40cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (55cm) Marvao Medical Devices, Ltd. MSD Class II 2015-03-31
K143609 Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter Olympus Surgical Technologies America FGE Class II 2015-03-27
K141715 GLOVE PORT Nelis GCJ Class II 2015-03-25
K142561 LM-9300 ELMA Lithotripter Lite-Med, Inc. LNS Class II 2015-03-20
DEN130047 PROLONG Ergon Medical , Ltd. PIA Class II 2015-03-20
K143313 NxStage Therapeutic Plasma Exchange (TPE) Cartridge Nxstage Medical, Inc. KDI Class II 2015-03-20
K143546 Imbibe Aspirating XIA Taps Stryker Corporation KNW Class II 2015-03-19
K143663 MiroCam Capsule Endoscope System Intromedic Co., Ltd. NEZ Class II 2015-03-17
K150225 NovaGold High Performance Guidewire Neometrics, Inc. OCY Class II 2015-03-16
K141164 ARTEMIS LIGHT ENGINE Quest Medical Imaging NTN Class II 2015-03-16
K150180 InTone Incontrol Medical, LLC KPI Class II 2015-03-16
K142068 BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE Medovations, Inc. OCX Class II 2015-03-10
K142464 Entriport Conmed Corporation GCJ Class II 2015-03-05
K143645 EsophyX® Z Fastener Delivery Device Endogastric Solutions, Inc. ODE Class II 2015-03-04
K143303 Single Use Biliary Balloon Dilator Olympus Medical Systems Corp. FGE Class II 2015-02-27
K143088 GastriSail Gastric Positioning System Covidien KNT Class II 2015-02-25
K143123 Synergetics PHOTON EX Synergetics MPA Class II 2015-02-24
K142128 KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR Covidien PNR Class II 2015-02-23
DEN140020 ECLIPSE SYSTEM Pelvalon PJH Class II 2015-02-12
K142680 ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT Olympus Medical Systems Corp. NEZ Class II 2015-02-08
K150127 Laparoscopic Handles with peek Insulation Stryker Endoscopy GCJ Class II 2015-02-04
K142767 ThinkMed Intermittent Catheter with/without Hydrophilic Coating Thinkmed Medical Technology Co., Ltd. GBM Class II 2015-02-03
K142989 Mini ONE Enteral Extension Set Applied Medical Technology, Inc. PIF Class II 2015-01-29
K140265 ELECTRODE FOR URINARY INCONTINENCE Guangzhou Finecure Medical Equipment Co.,Ltd KPI Class II 2015-01-23
K143299 Percuvance(R) Percutaneous Surgical System Teleflexmedical, Inc. GCJ Class II 2015-01-21
K142791 Spectra Soft Tissue Biopsy Needles Spectra Medical Devices KNW Class II 2015-01-21
K143182 Speedicath Compact Male Coloplast A/S GBM Class II 2015-01-20
K143634 MUSE System Medigus , Ltd. ODE Class II 2015-01-20
K142155 ENDOCHOICE WATER BOTTLE CAP SYSTEM Endochoice, Inc. FEQ Class II 2015-01-20
K131950 ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET Summit International Medical Technologies, Inc. FIE Class II 2015-01-16
K142922 SpyGlass DS Direct Visualization System Boston Scientific Corporation FBN Class II 2015-01-16
K142144 DISPOSABLE INJECTION NEEDLE Wilson Instruments (Shanghai) Company Limited FBK Class II 2015-01-15
K142792 AbbVie NJ AbbVie , Inc. KNT Class II 2015-01-14
K142793 AbbVie PEG AbbVie , Inc. KNT Class II 2015-01-14
K142816 AbbVie J AbbVie , Inc. KNT Class II 2015-01-14
K140984 TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM Tango3, LLC FIN Class II 2015-01-12
K143594 VaPro Pocket Hollister Incorporated GBM Class II 2015-01-09
K142635 Medline Silicone Foley Catheter Medline Industries, Inc. EZL Class II 2015-01-09
K142297 Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set Xeridiem (Formerly Mri) PIF Class II 2015-01-08
K142075 BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBE Xeridiem (Formerly Mri) PIF Class II 2015-01-08
K142539 EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set Zevex, Inc. PIF Class II 2015-01-08
K143378 AQUARIUS Gastrostomy Replacement Tube Degania Silicone , Ltd. KNT Class II 2014-12-29
K142564 JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) JMS North America Corporation FIE Class II 2014-12-23
K142427 TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25 Applied Medical Resources GCJ Class II 2014-12-23
K140977 EVOTECH ECR Advanced Sterilization Products FEB Class II 2014-12-22
K142194 CytoSure Urinary Access System Emmy Medical FAJ Class II 2014-12-19
K142688 Echotip Procore HD Ultrasound Biopsy Needle Cook Ireland, Ltd. FCG Class II 2014-12-19
K142483 TurboSEAL Nasogastric Aspiration Tube Turboseal, L.P. BSS Class II 2014-12-19
K141752 NXSTAGE SYSTEM ONE Nxstage Medical, Inc. ODN Class II 2014-12-19
K143186 Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector Erbe USA, Inc. OCX Class II 2014-12-18
K140284 GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM Given Imaging , Ltd. NEZ Class II 2014-12-17
K142377 The OnControl Bone Marrow Biopsy System by Vidacare Vidacare, LLC KNW Class II 2014-12-17
K140667 WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER Well Lead Medical Co., Ltd. EZL Class II 2014-12-15
K140593 ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE Cook, Inc. GCJ Class II 2014-12-15
K142477 Intact Advance and Intact Excision XL, Intact BLES Intact Medical Corporation KNW Class II 2014-12-15
K141213 AMERIWATER OZONE DISINFECTION SYSTEM Ameriwater FIN Class II 2014-12-10
K142683 12 mm Endoscopes and Accessories Intuitive Surgical, Inc. NAY Class II 2014-12-10
K142547 Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm Covidien GCJ Class II 2014-12-09
K143221 Schoelly Laparoscope Schoelly Fiberoptic GmbH GCJ Class II 2014-12-05
K143217 12 mm & Stapler Bladeless Obturators Intuitive Surgical, Inc. NAY Class II 2014-12-03
K142310 Stryker Infrared Fluorescence (IRF) Imaging System Stryker Endoscopy OWN Class II 2014-12-02
K142285 AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz Ameriwater FIP Class II 2014-12-01
K142973 Resolution Clip Boston Scientific Corporation PKL Class II 2014-12-01
K140884 SYMETREX LONG TERM HEMODIALYSIS CATHETER Phase One Medical MSD Class II 2014-11-26
K141158 APEX Incontrol Medical, LLC KPI Class II 2014-11-26
K143091 Surgisleeve Wound Protector Covidien, LLC GCJ Class II 2014-11-26
K141408 RESOLVE BILIARY LOCKING DRAINAGE CATHETER Merit Medical Systems, Inc. FGE Class II 2014-11-26
K143074 Sherpa Pak Cardiac Transport System Paragonix Technologies, Inc. MSB Class II 2014-11-25
K143054 Sherpa Pak Kidney Transport System Paragonix Technologies, Inc. KDN Class II 2014-11-25
K142012 FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS Corpak Medsystems PIF Class II 2014-11-20
K141794 ENDO-MARYLAND DISSECTOR Ovesco Endoscopy AG KGE Class II 2014-11-19
K140923 TRACTION POLYPECTOMY SNARE Ovesco Endoscopy AG FDI Class II 2014-11-18
K140085 UNIVERSA PERCULTANEOUS DRAINAGE CATHETER Cook Incorporated FEW Class II 2014-11-18
K140595 THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM Avantis Medical Systems, Inc. FDF Class II 2014-11-17
K142428 Shock Pulse-SE Lithotripsy System CYBERWAND II Cybersonics, Inc. FEO Class II 2014-11-13
K140492 NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE Marvao Medical Devices, Ltd. MSD Class II 2014-11-13
K141593 UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH Unimicro Medical Systems (Shenzhen) Co., Ltd. GCJ Class II 2014-11-13
K142903 neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US Neosurgical, Ltd. GCJ Class II 2014-11-12
K142950 Acrobat Calibrated Tip Wire Guide Wilson-Cook Medical, Inc. OCY Class II 2014-11-05
K142575 Bard RiteCath Intermittent Urinary Catheter C.R. Bard, Inc. EZD Class II 2014-10-31
K142563 Well Lead PVC Urethral Catheter Well Lead Medical Co., Ltd. EZD Class II 2014-10-28
K142425 Uroflowmeter Be Technologies, Inc. EXY Class II 2014-10-27
K141731 NEPHROS DSU-H, NEPHROS SSU-H Nephros, Inc. NHV Class II 2014-10-24
K142603 Stryker Precision HD Camera System Stryker Endoscopy GCJ Class II 2014-10-23
K142556 Flexible Video-Uretero-Choledochoscope System KARL STORZ Endoscopy-America, Inc. FGB Class II 2014-10-23
K141820 JAGWIRE HIGH PERFORMANCE GUIDWIRE Boston Scientific Corp OCY Class II 2014-10-21
K141344 EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM Boston Scientific Corp FAD Class II 2014-10-17

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