meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
51
Latest Decision
2013-01-17

Clearances · page 29 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K123110 PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301 Surgical Innovations Plc GCJ Class II 2013-01-17
K121421 FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) Fresenius Medical Care North America, Design Cente ONW Class II 2013-01-17
K123038 SWISS LITHOBREAKER E.M.S Electro Medical Systems S.A FFK Class II 2013-01-16
K123438 XENX STONE MANAGEMENT DEVICE Xenolith Medical OCY Class II 2013-01-10
K123223 EC SINGLE USE, POLYPECTOMY SNARE Endochoice, Inc. FDI Class II 2013-01-10
K123847 MALLEABLE TIP ENDOSCOPIC APPLICATOR Micromedics, Inc. GCJ Class II 2013-01-08
K123439 NEO ERCP GUIDEWIRE Neometrics, Inc. OCY Class II 2013-01-03
K123102 SOVEREIGN MINI Aesculap, Inc. GCJ Class II 2013-01-03
K113023 STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER Nxstage Medical, Inc. KDI Class II 2012-12-21
K121582 INVENDO C25 COLONOSCOPY SYSTEM Invendo Medical Gbmh FDF Class II 2012-12-20
K120357 ENDOSCOPE REPROCESSOR OER-MINI Olympus Medical Systems Corp. FEB Class II 2012-12-20
K123659 TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR) Actuated Medical, Inc. KNT Class II 2012-12-20
K123359 OVS1 VIDEO SYSTEM Olive Medical Corp. FCW Class II 2012-12-19
K121105 NUTRISAFE 2 FEEDING TUBE Vygon Corp. FPD Class II 2012-12-18
K113313 MOLECULAR ADSORBENT RECIRCULATING(MARS) Gambro Renal Products, Inc. FLD Class II 2012-12-14
K122831 VIDEO SYSTEM CENTER Olympus Medical Systems Corp. NTN Class II 2012-12-14
K123319 GYRUS ACMI BICOAG HEMOSTASIS PROBE Olympus Surgical Technologies America KNS Class II 2012-12-14
K113771 SIGNAL GEAR URETHRAL CATHETER ELECTRODE Neurovision Medical Products, Inc. FAP Class II 2012-12-13
K122649 NAVIGATOR HD URETERAL ACCESS SHEATH SET Boston Scientific Corp FED Class II 2012-12-12
K123317 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N Olympus Medical Systems Corporation FDS Class II 2012-12-11
K122740 JETPREP FLUSHING DEVICE OL-103037, JETPREP FLUSHING DEVICE OL-133037, JETPREP FLUSHING DEVICE OL-168037, JETPREP FLUSHIN Jetprep, Ltd. OCX Class II 2012-12-10
K122546 SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Idev Technologies, Inc. FGE Class II 2012-12-07
K121341 FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM Fresenius Medical Care North America KDI Class II 2012-12-06
K123463 INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS Intuitive Surgical, Inc. NAY Class II 2012-12-03
K122660 RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612 Boston Scientific Corporation PKL Class II 2012-12-03
K120862 WATER BOTTLE CAP IRRIGATON SYSTEM Endochoice, Inc. FEQ Class II 2012-11-27
K122526 360 GAS ASSISTED ENDOSCOPIC APPLICATOR Micromedics, Inc. GCJ Class II 2012-11-16
K123259 MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM Devicor Medical Products, Inc. KNW Class II 2012-11-15
K121599 CRIT-LINE CLIP (CLIC) Fresenius Medical Care-North America KOC Class II 2012-11-09
K122294 PRESSURIZED INFUSION PUMP Mui Scientific FFX Class II 2012-11-01
K122078 LOFRIC PRIMO, LOFRIC HYDRO-KIT Astra Tech, Inc. EZD Class II 2012-10-31
K122003 RENEW INSERT Renew Medical, Inc. PBP Class II 2012-10-26
K120127 SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM Swan Valley Medical, Incorporated KOB Class II 2012-10-26
K121921 INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS Intuitive Surgical, Inc. NAY Class II 2012-10-25
K122299 SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR Transenterix, Inc. GCJ Class II 2012-10-25
K122422 PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER Care Fusion PNG Class II 2012-10-24
K122924 CRE FIXED WIRE BALLON DILATION CATHETER Boston Scientific Corp KNQ Class II 2012-10-24
K113706 ENDOWRIST STAPLER SYSTEM Intuitive Surgical, Inc. NAY Class II 2012-10-17
K121796 WECK REUSABLE OBTURATOR Teleflexmedical, Inc. GCJ Class II 2012-10-11
K122816 AXCESS SOFT TIP WIRE GUIDE Wilson-Cook Medical, Inc. OCY Class II 2012-10-09
K121457 SPEEDICATH COMPACT SET (12 FR) Coloplast Corp. GBM Class II 2012-10-02
K122511 ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH Ethicon Endo-Surgery, LLC GCJ Class II 2012-10-01
K121458 SPEEDICATH COMPACT SET (12/18 FR) Coloplast A/S GBM Class II 2012-10-01
K122072 WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE Boston Scientific Corporation FGE Class II 2012-09-28
K122270 OVERTUBE ENDOSCOPIC ACCESS SYSTEM Apollo Endosurgery, Inc. FED Class II 2012-09-28
K120289 PEERSCOPE SYSTEM Peermedical FDF Class II 2012-09-28
K112628 NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET Nipro Medical Corporation FJK Class II 2012-09-28
K113120 CHF-Y0005 Olympus Medical Systems Corp. FBN Class II 2012-09-25
K121656 GEMINI LITHOTRIPTER Dornier Medtech America, Inc. LNS Class II 2012-09-24
K121848 SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM Medical Components, Inc. MSD Class II 2012-09-21
K121724 ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 Richard Wolf Medical Instruments Corp. FCW Class II 2012-09-20
K121022 AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV Ameriwater FIP Class II 2012-09-17
K122593 PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 Optim, LLC FEH Class II 2012-09-13
K121112 STRYKER VIDEO URETEROSCOPE Stryker Endoscopy FGB Class II 2012-09-12
K120766 ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION) Prosurg, Inc. FAJ Class II 2012-09-11
K120012 INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS Integra LifeSciences Corporation GCJ Class II 2012-09-11
K122462 ROTH NET RETRIEVER United States Endoscopy Group, Inc. FDI Class II 2012-09-11
K120126 BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE Barosense, Inc. FED Class II 2012-09-10
K121309 ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE Advanced Surgical Concepts OTJ Class II 2012-09-06
K120814 PADLOCK CLIP-12 Aponos Medical Corp. PKL Class II 2012-09-06
K121893 STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM Stryker Endoscopy GCJ Class II 2012-09-05
K122030 LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON Degania Silicone , Ltd. KNT Class II 2012-09-05
K121383 PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS) Medical Components, Inc. FJS Class II 2012-09-05
K122042 CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES Mauna Kea Technologies OWN Class II 2012-09-04
K122565 ARC ENDOCUFF Boddingtons Plastics, Ltd. FED Class II 2012-09-04
K121505 DISPOSABLE HEMOSTASIS CHIP Wilson-Cook Medical Inc./Cook Endoscopy PKL Class II 2012-08-31
K120997 BAROSTAT SOFTWARE OPTION Crospon, Ltd. FFX Class II 2012-08-27
K121820 INWAVE Zynex Medical, Inc. KPI Class II 2012-08-24
K121181 SWANNSHIDI BONE MARROW ASPIRATION NEEDLE Alliance Partners, LLC KNW Class II 2012-08-22
K113062 ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES Endoservice Optical Instruments GmbH FBP Class II 2012-08-21
K111627 SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Idev Technologies, Inc. FGE Class II 2012-08-21
K121497 VENOFER PUMP Renal Solutions, Inc. KDI Class II 2012-08-17
K122203 TRUETOME Boston Scientific Corp KNS Class II 2012-08-17
K120446 FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2 Fujinon, Inc. FDS Class II 2012-08-13
K120278 WIRELESS IMAGE TRANSMITTER UNIT Olympus Medical Systems Corp. GCJ Class II 2012-08-10
K113692 XENX Xenolith Medical OCY Class II 2012-08-09
K120898 KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA Richard Wolf Medical Instruments Corp. OTJ Class II 2012-08-03
K121337 UROPLASTY RIGID ENDOSCPIC NEEDLES Uroplasty, Inc. FBK Class II 2012-08-03
K121014 SOLAR GI Medical Measurement Systems B.V. FFX Class II 2012-08-01
K121604 ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT Obp Corporation FER Class II 2012-07-27
K112391 FUJINON COLONOSCOPES Fujinon, Inc. FDF Class II 2012-07-26
K121832 RESOLVE BILIARY LOCKING DRAINAGE CATHETER Merit Medical Systems, Inc. FGE Class II 2012-07-17
K121833 OSTOMY IRRIGATION SET Coloplast A/S EXD Class II 2012-07-16
K120468 NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR Cook Incorporated GCJ Class II 2012-07-06
K121125 FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM Flexible Stenting Solutions, Inc. FGE Class II 2012-07-06
K112331 BIOPURE PORTABLE RO SYSTEMS Arion Water, Inc. FIP Class II 2012-07-05
K121701 SYSTEMS INTEGRATION Olympus Medical Systems Corp. GCJ Class II 2012-06-29
K112318 CLEARPATH 24 Promedic, Inc. OCX Class II 2012-06-29
K113582 ARCHSTENT BILIARY SYSTEM Ostial Corporation FGE Class II 2012-06-29
K120611 SONY PVM-2551MD OLED MONITOR Sony Electronics, Inc. GCJ Class II 2012-06-28
K120002 I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE Busse Hospital Disposables, Inc. KNW Class II 2012-06-26
K113873 PENTAX EPK-I5020 VIDEO PROCESSOR Pentax of America, Inc. FET Class II 2012-06-22
K113566 OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM Life Technologies, Inc. NDS Class II 2012-06-21
K120524 SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM Mui Scientific FFX Class II 2012-06-21
K120567 GYRUS AMCI PK BUTTON ELECTRODE Gyrus Acmi, Inc. FAS Class II 2012-06-20
K120418 ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES Olympus Winter & Ibe GmbH FAS Class II 2012-06-20
K113310 ENDOGATER AVANTAGE CO2 INSUFFLATOR Byrne Medical, Inc. FCX Class II 2012-06-20
K120823 BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS Fresenius Medical Care North America, Design Cente FJK Class II 2012-06-15
K121571 TUBECLEAR Actuated Medical, Inc. KNT Class II 2012-06-13
K120769 MODULTH SLK KARL STORZ Endoscopy-America, Inc. LNS Class II 2012-06-12

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