meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
48
Latest Decision
2014-10-17

Clearances · page 26 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K141335 EXPEL APD DRAINAGE CATHETER SYSTEM Boston Scientific Corp FGE Class II 2014-10-17
K140581 CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT Cedic S.R.L. PIO Class II 2014-10-17
K141753 AQUARIUS NASAL FEEDING TUBE Degania Silicone , Ltd. PIF Class II 2014-10-16
DEN130044 INFLOW INTRAURETHRAL VALVE-PUMP Vesiflo, Inc. PIH Class II 2014-10-14
K140938 OSTOM-I ALERT 11 Health and Technologies, LLC EXB Class I 2014-10-10
K131925 HS NOTA H.S. Hospital Services S.P.A. FCG Class II 2014-10-10
K141894 SHARKCORE FINE NEEDLE BIOPSY SYSTEM Covidien, LLC( Formerly Beacon Endoscopic Corp.) FCG Class II 2014-10-06
K141286 AER-O-SCOPE COLONOSCOPE SYSTEM Gi View , Ltd. FDF Class II 2014-09-30
K142113 ESOPHYX2 HD Endogastric Solutions, Inc. ODE Class II 2014-09-30
K141598 FUSE COLONOSCOPY SYSTEM Endochoice, Inc. FDF Class II 2014-09-30
K142258 PolyCatch Retrieval Device Medi-Globe Corporation FDI Class II 2014-09-30
K141075 SINGLE-SITE WRISTED NEEDLE DRIVER Intuitive Surgical NAY Class II 2014-09-26
K131817 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER Osmunda Medical Device Consulting Co., Ltd. LNS Class II 2014-09-26
K142000 ESOFLIP ES Crospon, Ltd. PIE Class II 2014-09-25
K141358 CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES Mauna Kea Technologies OWN Class II 2014-09-25
K133456 POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER C.R. Bard, Inc. NIE Class II 2014-09-24
K142397 Predicate III Guidewire Lake Region Medical OCY Class II 2014-09-19
K123329 DA VINVI SURGICAL SYSTEM Intuitive Surgical, Inc. NAY Class II 2014-09-17
K140841 TABLO CARTRIDGE Home Dialysis Plus FJK Class II 2014-09-11
K140991 RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE Ranfac, Corp. KNW Class II 2014-09-11
K134019 MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO Nxstage Medical, Inc. FIE Class II 2014-09-11
K140866 TABLO CONSOLE Home Dialysis Plus KDI Class II 2014-09-10
K133976 FUJIFILM ENDOSCOPIC CO2 REGULATOR Fujifilm Medical System U.S.A., Inc. FCX Class II 2014-09-09
K141552 ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS Care Fusion KNW Class II 2014-09-05
K141673 IVAS 8 GAUGE BONE BIOPSY KIT Stryker Corporation KNW Class II 2014-09-04
K140947 COMPAT ENTERAL DELIVERY PUMP SETS Nestle Healthcare Nutrition, Inc. PIF Class II 2014-09-04
K141272 FLOSHIELD 10MM ENDOSCOPIC CANNULA AND BLUNT OBTURATOR, FLOSHIELD 10MM ENDOSCOPIC CANNULA, FLOSHIELD 10MM BLUNT OBTURATOR Minimmally Invasive Devices GCJ Class II 2014-09-04
K133724 MINNCARE HD Medivators, Inc. NIH Class II 2014-08-27
K133334 VERITRACT ENTERAL FEEDING TUBE SYSTEM Veritract, Inc. KNT Class II 2014-08-26
K141597 MUSTANG BALLOON DIALATION CATHETER Boston Scientific Corporation FGE Class II 2014-08-22
K140149 EPX-4440HD DIGITAL VIDEO PROCESSOR Fujifilm Medical Systems U.S.A, Inc. PEA Class II 2014-08-22
K141642 VAPRO INTERMITTENT CATHETER Hollister Incorporated GBM Class II 2014-08-22
K140945 COMPACTCATH INTERMITTENT URINARY CATHETER Compactcath, Inc. EZD Class II 2014-08-22
K141281 CRIT-LINE CLIP (CLIC) BLOOD CHAMBER Fresenius Medical Care Renal Therapies Group, LLC KOC Class II 2014-08-14
K141077 DA VINCI FIREFLY IMAGING SYSTEM Intuitive Surgical, Inc. NAY Class II 2014-08-12
K133538 VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE Olympus Corporation of the Americas NWB Class II 2014-08-07
K141592 UNIMICRO SUCTION IRRIATION TUBING SET Unimicro Medical Systems (Shenzhen) Co., Ltd. GCJ Class II 2014-08-04
K141058 ENSIZOR ENDOSCOPIC SCISSORS Slater Endoscopy, LLC OCZ Class II 2014-08-01
K140953 GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER Convatec, Ltd. KOD Class II 2014-08-01
K141145 LIBERTY PDX CYCLER Fresenius Medical Care Renal Therapies Group, LLC FKX Class II 2014-07-30
K133311 ENDOLED Olympus Winter & Ibe GmbH NTN Class II 2014-07-30
K141631 AQUARIUS EXTENSION FEEDING SET Degania Silicone , Ltd. KNT Class II 2014-07-28
K133077 GENERICA MEDICAL ENTERNAL DELIVERY; PUMP BAG SET, PUMP SPIKE SET, GRAVITY BAG SET Generica Medical International, Inc. KNT Class II 2014-07-28
K140553 ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS Intuitive Surgical, Inc. NAY Class II 2014-07-25
K133466 CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM) Mauna Kea Technologies OWN Class II 2014-07-25
K131226 NOVAPROBE LED LIGHT SOURCE Novaprobe Incorporated FCW Class II 2014-07-24
K140295 GIS ENDOSCOPIC OPTICAL LENS Gi Scientific, LLC FDS Class II 2014-07-24
K140523 RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM Coloplast A/S FED Class II 2014-07-24
K131721 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1 Comed Medical Systems Co., Ltd. LNS Class II 2014-07-22
K140726 CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIV Boston Scientific Corp FDI Class II 2014-07-21
K140753 ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM Medivators OCX Class II 2014-07-15
K140101 ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS Ab Medica Sas GCJ Class II 2014-07-10
K134005 MIROCAM CAPSULE ENDOSCOPE SYSTEM Intromedic Co., Ltd. NEZ Class II 2014-07-09
K141051 VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU Arrow International, Inc. MSD Class II 2014-07-07
K133299 ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY Fresenius Medical Care, North America - Renal Ther KDI Class II 2014-07-07
K133110 EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM Boston Scientific Corporation FGE Class II 2014-07-02
K140751 MIROCAM CAPSULE ENDOSCOPE SYSTEM Intromedic Co., Ltd. NEZ Class II 2014-06-30
K133465 CONSURE STOOL MANAGEMENT SYSTEM Consure Medical Pvt , Ltd. KNT Class II 2014-06-26
K133087 ABBVIE PEG AbbVie , Inc. KNT Class II 2014-06-19
K133129 ABBVIE NJ AbbVie , Inc. KNT Class II 2014-06-19
K133096 ABB VIE J AbbVie , Inc. KNT Class II 2014-06-18
K141363 CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETER Merit Medical Systems, Inc. MSD Class II 2014-06-18
K140441 BI-FLEX URETERAL ACCESS SHEATH Promepla Sam KNY Class II 2014-06-17
K140623 NXSTAGE EXPRESS FLUID WARMER Nxstage Medical, Inc. FLA Class II 2014-06-16
K140562 WIJAY EZ-VOID EXTERNAL CATHETER VALVE Leomed, LLC KNY Class II 2014-06-16
K140760 BONASTENT BILIARY Endochoice, Inc. FGE Class II 2014-06-16
K133439 PILLING ESOPHAGEAL BOUGIES Teleflexmedical, Inc. FAT Class II 2014-06-16
K132375 GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG Genicon GCJ Class II 2014-06-12
K140662 FLEX ENDOSCOPIC INSTRUMENTS Design Standards Corp. GCJ Class II 2014-06-11
K141250 FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM KARL STORZ Endoscopy-America, Inc. FGB Class II 2014-06-11
K141252 GUARDIAN URETHRAL SHEATH Solace Therapeutics KNY Class II 2014-06-09
K140189 ENDOWRIST VESSEL SEALER Intuitive Surgical, Inc. NAY Class II 2014-06-05
K141323 VTI SUCTION IRRIGATION SYSTEM Regulatory Technology Services, LLC GCJ Class II 2014-06-04
K131183 MED-RX ORAL/ENTERAL SYRINGE Benlan, Inc. KNT Class II 2014-06-03
K140630 WALLFLEX BILIARY RX STENT SYSTEM Boston Scientific FGE Class II 2014-05-23
K133694 SHERPA PAK TRANSPORTER Paragonix Technologies, Inc. KDN Class II 2014-05-23
K140526 NXSTAGE SYSTEM ONE Nxstage Medical, Inc. KDI Class II 2014-05-19
K140571 NXSTAGE PUREFLOW SL Nxstage Medical, Inc. FKR Class II 2014-05-15
K133763 SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM Medi-Globe Corporation FCG Class II 2014-05-15
K133700 ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS Boston Scientific Corporation FGE Class II 2014-05-14
K133148 BIOMARC COAXIAL NEEDLE Carbon Medical Technologies, Inc. FBK Class II 2014-05-13
K133272 VERSACUT + TISSUE MORCELLATOR Lumenis, Ltd. GCJ Class II 2014-05-13
K132686 AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE Degania Silicone , Ltd. KNT Class II 2014-05-12
K133251 BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM C.R. Bard, Inc. KNT Class II 2014-05-09
K133203 SINGLE-SITE PORT Intuitive Surgical, Inc. GCJ Class II 2014-05-09
K132475 FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM Fluoptics OWN Class II 2014-05-07
K133149 BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM Mar Cor Purification, Inc. FIP Class II 2014-04-30
K130889 SPLIT CATH RG Medcomp MSD Class II 2014-04-28
K140763 MONOFILAMENT POLYPECTOMY SNARE United States Endoscopy FDI Class II 2014-04-24
K140561 AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT) Xlumena, Inc. PCU Class II 2014-04-23
K133829 AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF Vivonic GmbH FIP Class II 2014-04-22
K131852 HC-1 AND HC-1 CLASSIC Transcendencias Comerciales SL Transcom KPL Class II 2014-04-17
K131962 DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES Intuitive Surgical, Inc. NAY Class II 2014-04-17
K133783 AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION Ameriwater FIP Class II 2014-04-16
K140191 ELISIO-H HEMODIALYZER Nipro Medical Corporation KDI Class II 2014-04-14
K133345 REVEEL ENDOSCOPIC RETRACTOR Retraction Limited GCJ Class II 2014-04-11
K131902 PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY) Pentax Medical Company FDS Class II 2014-04-10
K123555 KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY Covidien KNT Class II 2014-04-09
K131855 PENTAX VIDEO COLONOSCOPES (EC FAMILY) Pentax Medical Company FDF Class II 2014-04-09
K140482 MANDREL GUIDEWIRE Lake Region Medical OCY Class II 2014-04-08

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