meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
52
Latest Decision
2017-12-29

Clearances · page 20 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K171573 Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush Wilson-Cook Medical, Inc. FDX Class II 2017-12-29
K173087 UroLift System (UL400 and UL500) Neotract, Inc. PEW Class II 2017-12-28
K171043 Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters Coloplast Corp. EYB Class II 2017-12-21
K170862 Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope Solace Therapeutics, Inc. FAJ Class II 2017-12-19
K172677 Advantage Plus Pass-Thru Medivators, Inc. FEB Class II 2017-12-19
K172844 Cellvizio 100 Series System with Confocal Miniprobes Mauna Kea Technologies OWN Class II 2017-12-15
K173687 Strange Bile Duct Stone Exploration Set Cook Incorporated LQR Class II 2017-12-15
K172238 CAREline Airless Hemodialysis Blood Tubing Sets Fresenius Medical Care Renal Therapies Group, LLC KOC Class II 2017-12-14
K170790 SAM CRRT Unit, SAM Cassette CRRT Spectral Medical, Inc. KDI Class II 2017-12-13
K172217 Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath Cook Incorporated FED Class II 2017-12-13
K173392 Pure-Vu System Motus GI Medical Technologies , Ltd. FDF Class II 2017-12-12
K170898 Wittich Nitinol Stone Basket Cook Incorporated LQR Class II 2017-12-12
K171956 Sterile Endoscope Biopsy Sampling Needle Changzhou Detain Medical Devices Co., Ltd. FCG Class II 2017-12-12
K171336 Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath Henke-Sass, Wolf GmbH FAJ Class II 2017-12-07
K172734 Single Use Electrosurgical Snare SD-400 Olympus Medical Systems Corp. FDI Class II 2017-12-07
K172578 Equipment Pouch Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd GCJ Class II 2017-12-07
K172618 SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1 Olympus Medical Systems Corp. GCJ Class II 2017-12-05
K172666 CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor Sutureease, Inc. OCW Class II 2017-12-01
K171571 NexSite HD, Hemodialysis Step Tip Catheter (60cm) Marvao Medical Devices, Ltd. MSD Class II 2017-11-30
K172794 Suction Irrigation Set Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd GCJ Class II 2017-11-29
K170811 Single Use Retrieval Nitinol Basket V Olympus Medical Systems Corp. LQR Class II 2017-11-27
K172128 EsoFLIP® ES-310 Balloon Catheter Crospon, Ltd. PIE Class II 2017-11-22
K172278 Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent Cook Incorporated GBM Class II 2017-11-22
K172924 GentleCath Intermittent Urinary Catheter Convatec Limited KOD Class II 2017-11-21
K173355 Gastric Sizing Balloon Catheter Cook Incorporated KNT Class II 2017-11-17
K171158 Single Use Electrosurgical knife Olympus Medical Systems Corp. KNS Class II 2017-11-17
K171618 Symetrex Long Term Hemodialysis Catheter Medcomp (Dba Medical Components, Inc.) MSD Class II 2017-11-16
K170362 VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS Coloplast Corp. FAD Class II 2017-11-15
K171886 OverStitch SX Endoscopic Suturing System (ESS) Apollo Endosurgery, Inc. OCW Class II 2017-11-15
K172344 Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) Medax Srl Unipersonale KNW Class II 2017-11-13
K173009 NCompass Nitinol Stone Extractors Cook Incorporated LQR Class II 2017-11-07
K170405 BD Curve Ascites Shunt Care Fusion KPM Class II 2017-11-02
K170422 BIOSOFT DUO DOUBLE LOOP URETERAL STENTS Coloplast Corp. FAD Class II 2017-11-02
K172038 Trocar Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd GCJ Class II 2017-10-27
K173184 Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle Boston Scientific ODG Class II 2017-10-27
K170371 DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe Intervene Group Limited PNR Class II 2017-10-20
K170150 Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags S.A.L.F. Spa KDL Class II 2017-10-20
K172811 EsophyX Z, EsophyX2 HD Endogastric Solutions, Inc. ODE Class II 2017-10-19
K172940 ANCHOR Tissue Retrieval System Conmed Corporation GCJ Class II 2017-10-18
K172817 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA Olympus Medical Systems Corp. FET Class II 2017-10-17
K171916 Single Use Hot Biopsy Forceps FD-231 Olympus Medical Systems Corp. KGE Class II 2017-10-13
K171548 Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter Wilson-Cook Medical, Inc. FGE Class II 2017-10-13
K170233 Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) Zhanjiang Star Enterprise Co., Ltd. EZD Class II 2017-10-13
K171015 Citryte Di-Chem, Inc. KPO Class II 2017-10-13
K171120 Senhance Surgical Robotic System Transenterix, Inc. NAY Class II 2017-10-13
K162340 Stomach Tube Well Lead Medical Co., Ltd. KNT Class II 2017-10-11
K170319 Low Profile Non-Balloon Feeding Device Applied Medical Technology, Inc. KNT Class II 2017-10-06
K172097 Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves Renovo, Inc. NLM Class II 2017-10-06
K170672 Tamper Evident Cap For use with ENFit Syringes International Medical Industries, Inc. PNR Class II 2017-10-06
K172672 Endoscopic Applicator, 41 cm Micromedics, Inc. (D/B/A Nordson Medical) GCJ Class II 2017-10-06
K172093 Reprocessed Covidien Trocar Renovo, Inc. NLM Class II 2017-10-05
K172558 iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit Stryker Corporation KNW Class II 2017-10-05
K172289 pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent Q Urological Corporation FAD Class II 2017-10-04
K172520 CRE RX Biliary Balloon Dilatation Catheter Boston Scientific Corporation FGE Class II 2017-10-04
K172285 Ablatherm Fusion Edap Technomed, Inc. PLP Class II 2017-10-03
K172309 Endoscopic Ultrasound Aspiration Needle Micro-Tech (Nanjing) Co., Ltd. ODG Class II 2017-09-29
K171965 Resection Electrodes with HF cable Olympus Winter & Ibe GmbH FAS Class II 2017-09-28
K170162 Vesco Medical Nasoenteric Feeding Tubes Vesco Medical, LLC PIF Class II 2017-09-26
K171726 LapBag Sejong Medical Co., Ltd. GCJ Class II 2017-09-25
K170879 IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories Intuitive Surgical, Inc. NAY Class II 2017-09-21
K170641 da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes Intuitive Surgical, Inc. NAY Class II 2017-09-21
K163614 PENTAX Medical ED34-i10T, Video Duodenoscope Pentax Medical FDT Class II 2017-09-20
K170292 Tri-Ex Extraction Balloon With Multiple Sizing Wilson-Cook Medical, Inc. GCA Class II 2017-09-20
K172247 Magic3 Go Intermittent Urinary Catheter C.R. Bard, Inc. EZD Class II 2017-09-20
K171632 da Vinci Xi Surgical System Intuitive Surgical, Inc. NAY Class II 2017-09-19
K172299 Accordion Piccolo Stone Management Device Ths International, Inc. D/B/A Accordion Medical FFL Class II 2017-09-19
K171652 Fresenius Liberty Select Cycler Fresenius Medical Care Renal Therapies Group, LLC FKX Class II 2017-09-15
K172120 Veress Needle Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd FHO Class II 2017-09-14
K170323 Entuit Start Initial Placement Gastrostomy Set Cook Incorporated KGC Class II 2017-09-14
K171953 Bard Mission Disposable Core Biopsy Instrument Bard Peripheral Vascular, Inc. KNW Class II 2017-09-14
K170875 da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories Intuitive Surgical, Inc. NAY Class II 2017-09-12
K170645 da Vinci Xi EndoWrist Instruments and Accessories Intuitive Surgical, Inc. NAY Class II 2017-09-11
K170644 da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm) Intuitive Surgical, Inc. NAY Class II 2017-09-11
K171531 Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle Care Fusion KNW Class II 2017-09-11
K170487 Navina Classic System Dentsply Sirona KNT Class II 2017-09-11
K170210 PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 Given Imaging , Ltd. NEZ Class II 2017-09-01
K172098 Medical Video Endoscope System Zhuhai Pusen Medical Technology Co., Ltd. FGB Class II 2017-08-31
K171741 Laport Sejong Medical Co., Ltd. GCJ Class II 2017-08-29
K170010 Salle Intraoperative Pyeloplasty Stent Set Cook Incorporated FAD Class II 2017-08-28
K171331 NxStage System One Nxstage Medical, Inc. KDI Class II 2017-08-24
K172227 Endoscopic Injection Needle Carbon Medical Technologies, Inc. FBK Class II 2017-08-23
K171024 ShockPulse-SE Lithotripsy System Cybersonics, Inc. FEO Class II 2017-08-21
K172359 UroLift System (UL500) Neotract, Inc. PEW Class II 2017-08-18
K171475 DeRoyal Laprador Specimen Retrieval System Deroyal Industries, Inc. GCJ Class II 2017-08-17
K170555 U Deliver Bolink ENFit Enteral Feeding Sets U Deliver Medical, LLC PIF Class II 2017-08-17
K171983 Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory Creo Medical, Ltd. KNS Class II 2017-08-17
K170531 Ureteral Dilators and Percutaneous Nephrostomy Dilators Coloplast Corp. EZN Class II 2017-08-17
K171993 Zimmon Needle Knife Papillotome Wilson-Cook Medical Inc./Cook Endoscopy KNS Class II 2017-08-17
K170574 Diacap Pro Dialyzer B. Braun Avitum AG KDI Class II 2017-08-11
K171809 Epic Biliary Endoscopic Stent System Boston Scientific Corporation FGE Class II 2017-08-09
K172084 Delta III Lithotripter Dornier Medtech America, Inc. LNS Class II 2017-08-08
K171596 ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle Wilson-Cook Medical, Inc. FCG Class II 2017-08-04
K171345 Cellvizio 100 Series Systems with Confocal Miniprobes Mauna Kea Technologies OWN Class II 2017-08-04
K172036 Medrobotics Flex Robotic System Medrobotics Corporation FDF Class II 2017-08-03
K171619 14Fr Colon Decompression Set, Macon Colon Decompression Set Cook Ireland, Ltd. FEG Class II 2017-08-01
K171623 Nasal Pancreatic Drainage Set Cook Ireland, Ltd. FGE Class II 2017-07-31
K171607 Bronchi and Gastrointestinal Cytology Brush Wilson-Cook Medical Inc./Cook Endoscopy FDX Class II 2017-07-31
K171699 da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System Intuitive Surgical, Inc. NAY Class II 2017-07-28
K171602 Williams Cystoscopic Injection Needle Cook Incorporated FBK Class II 2017-07-28
K170867 FTRD System Set Ovesco Endoscopy AG PKL Class II 2017-07-25

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