meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
46
Latest Decision
1997-07-29

Clearances · page 59 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K971764 WELCON HUE-VU URINARY DRAINAGE BAG Welcon, Inc. KNX Class II 1997-07-29
K972266 GALLINI COAXIAL INTRODUCER Gallini U.S., LLC KNW Class II 1997-07-29
K971571 RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT Waters Instruments, Inc. KDN Class II 1997-07-29
K971734 VG 200 VIDEO GASTROSCOPE Welch Allyn, Inc. FDS Class II 1997-07-29
K971660 OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT Olympus America, Inc. FDS Class II 1997-07-25
K971512 AMS COAGULOOP RESECTION ELECTRODE American Medical Systems, Inc. FAS Class II 1997-07-24
K970989 CYBERREN Cybernius Medical , Ltd. KPF Class II 1997-07-24
K971615 PATTISON ESOPHAGEAL DILATOR Tri-Med Specialties, Inc. KNQ Class II 1997-07-24
K971180 BARD NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT C.R. Bard, Inc. KDI Class II 1997-07-24
K971801 LAPAROTOMY BLADDER NECK SUSPENSION KIT Louisville Laboratories, Inc. EZL Class II 1997-07-22
K970178 CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM Corpak, Inc. KNT Class II 1997-07-21
K961392 ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II Sil-Med Corp. FJS Class II 1997-07-18
K971598 STERICHEK CHLORINE REAGENT STRIPS Environmental Test Systems, Inc. MSY Class II 1997-07-18
K971416 OLYMPUS OES OTV-S5C VIDEO SYSTEM Olympus America, Inc. FET Class II 1997-07-16
K963565 MRI NEEDLES Cook, Inc. FCG Class II 1997-07-14
K964920 RPI DUAL PORT IRRIGATION ADAPTER Ridge Products, Inc. KNT Class II 1997-07-09
K970739 RMI HEMOCONCENTRATOR PREFERENCE PACK Research Medical, Inc. KDI Class II 1997-07-08
K961465 2008H ON LINE CLEARANCE MONITOR Fresenius USA, Inc. KDI Class II 1997-07-03
K971328 OLYMPUS CD-6C-1 COAGULATION ELECTRODE Olympus America, Inc. FFE Class II 1997-07-01
K971527 INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM Empi KPI Class II 1997-06-30
K965147 BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS Boston Scientific Corp FGE Class II 1997-06-30
K970720 ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER AND THE ENDOPATH EZ45 NO KNIFE ENDOSCOPIC LINEAR STAPLER Ethicon Endo-Surgery, Inc. OCW Class II 1997-06-27
K963160 HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE Olympus America, Inc. PKL Class II 1997-06-27
K964131 ENDOSCOPE Akos Biomedical, Inc. FAM Class II 1997-06-27
K971123 STONE EXTRACTOR Phx Technologies Corp. OCZ Class II 1997-06-27
K971679 I-SCOPE OPHTHALMIC ENDOSCOPE Ophthalmic Technologies, Inc. MPA Class II 1997-06-25
K971541 VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON Hollister, Inc. KPI Class II 1997-06-25
K964757 CONTIDRAIN CATHETER Contimed, Inc. EZL Class II 1997-06-25
K970882 ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.) American Medical Devices, Inc. MPA Class II 1997-06-24
K964688 LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENT Cordis Corp. FGE Class II 1997-06-20
K971842 COAXIAL NEEDLE United States Endoscopy Group, Inc. FCG Class II 1997-06-20
K970083 DYNABITE HOT GI BIOPSY FORCEPS Portlyn Corp. KGE Class II 1997-06-17
K971053 ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS International Medical Products, Inc. KPO Class II 1997-06-16
K964264 HIGH RANGE PEROXIDE TEST STRIP Integrated Biomedical Technology, Inc. FKP Class II 1997-06-16
K971230 SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT Innerdyne, Inc. KNT Class II 1997-06-13
K971334 PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR Pilling Weck Group GCJ Class II 1997-06-11
K961711 ASPISAFE GASTRIC TUBE B.Braun Medical, Inc. BSS Class II 1997-06-11
K970946 MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET Medline Industries, Inc. LJH Class II 1997-06-10
K970917 SOLOS 10MM OPERATING LAPAROSCOPE Woodbine Optical Corp. GCJ Class II 1997-06-10
K964005 SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE Synergetics, Inc. MPA Class II 1997-06-09
K964634 ANOKRYO Mk Conquest Intl., Inc. FFP Class I 1997-06-06
K963064 ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM Laborie Medical Tech Corp. FFX Class II 1997-06-05
K971911 LUMAX CYSTOMETRY ADMINISTRATION TUBE SET Medamicus, Inc. FEN Class II 1997-06-03
K970446 DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM Althin Medical AB an Affiliate of Baxter Intl KDI Class II 1997-06-02
K970526 ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP Arthrocare Corp. FAS Class II 1997-05-28
K971202 COMEG OPTICAL STONE CRUSHING FORCEPS, COMEG VISUAL OBTURATORS FOR UROLOGY, COMEG OPTICAL BIOPSY FORCEPS Comeg Endoskopie GmbH OCZ Class II 1997-05-27
K971204 LSVP INTERNATIONAL HOT BIOPSY FORCEPS Lsvp Intl., Inc. KGE Class II 1997-05-27
K971125 ENDO SMARTCAP (100501) Endo Smart Cap Co. OCX Class II 1997-05-23
K971584 CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES) Clarus Medical Systems, Inc. OCV Class II 1997-05-23
K970077 LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044) Utah Medical Products, Inc. KPI Class II 1997-05-23
K963779 RUSCH ENTERAL FEEDING TUBE Rusch, Inc. FPD Class II 1997-05-23
K970890 #ES-32 SUCTION CATHETER 32 FR. Tri-Med Specialties, Inc. KNT Class II 1997-05-23
K964337 BETTER-BLADDER (BB) Circulatory Technology, Inc. FIB Class II 1997-05-23
K971275 MILL-ROSE DISPOSABLE POLYPECTOMY SNARE Mill-Rose Laboratory FDI Class II 1997-05-23
K970900 INSTRUMENT HOLDER Contour Fabricators, Inc. GCJ Class II 1997-05-22
K970605 3-CCD DIGITAL CAMERA Envision Medical Corp. GCJ Class II 1997-05-22
K970871 TR NEEDLE Gallini Intl., Inc. KNW Class II 1997-05-21
K970872 PAN (CHIBA ASPIRATING NEEDLE) Gallini Intl., Inc. KNW Class II 1997-05-21
K964922 DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM Althin Medical AB an Affiliate of Baxter Intl KDI Class II 1997-05-21
K963254 SYMPHONY NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Boston Scientific Corp FGE Class II 1997-05-21
K970875 ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.) American Medical Devices, Inc. MPA Class II 1997-05-20
K962009 UROSTYM Laborie Medical Technologies, Ltd. KPI Class II 1997-05-20
K971455 CLARUS MODEL 5197 SIGHTLITE Clarus Medical Systems, Inc. FTI Class II 1997-05-20
K971373 VISTA SINGLE CHIP VIDEO CAMERA Vista Medical Technologies, Inc. FET Class II 1997-05-20
K962899 ULTRAFLEX DIAMOND Boston Scientific Corp FGE Class II 1997-05-20
K964825 FREEDOM TRAVELLER Impact Case Technologies, Inc. MLW Class II 1997-05-19
K963767 MANAN V.S. ACCESS NEEDLE/SET Manan Medical Products, Inc. FGE Class II 1997-05-16
K970716 OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE Opticon Medical, Inc. EZL Class II 1997-05-16
K970799 ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T) Alexander Mfg. Co. LIF Class II 1997-05-14
K964405 MBI ILLUMINATED RETINAL PICK M.B. Industries, Inc. MPA Class II 1997-05-13
K964553 MBI CO-AXIAL ILLUMINATED RETINAL PICK M.B. Industries, Inc. MPA Class II 1997-05-13
K970536 MEDISYSTEMS TRANDUCER PROTECTOR Medisystems Corp. FIB Class II 1997-05-12
K970982 T-RX RETRIEVAL FORCEPS Tri-Med Specialties, Inc. OCZ Class II 1997-05-09
K970717 VAPOR-TECH SLED ELECTRODE Northgate Technologies, Inc. FAS Class II 1997-05-08
K970945 ANGLED TIP POLYPECTOMY SNARE United States Endoscopy Group, Inc. KNS Class II 1997-05-07
K970878 ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT American Medical Devices, Inc. MPA Class II 1997-05-06
K971338 SYNTEC, INC. DISPOSABLE BARE END FIBER Syntec, Inc. MPA Class II 1997-05-06
K970892 FIEGERT ENDOTECH CYSTOSCOPE Fiegert, Inc. FAJ Class II 1997-05-05
K960068 SH-1 SURGICAL HOLDER FOR TELESCOPE Olympus America, Inc. OCV Class II 1997-05-05
K971498 APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE Applied Medical Resources EZB Class I 1997-05-05
K963166 O'REGAN LIGATOR Patrick J. O'Regan FHN Class II 1997-05-05
K963782 BARD MEMOTHERM TRANSHEPATIC BILIARY ENDOPROSTHESIS C.R. Bard, Inc. FGE Class II 1997-05-02
K955592 COBE CENTRYSYSTEM 14 PES HEMODIALYZERS Cobe Renal Care, Inc. KDI Class II 1997-04-30
K964119 WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS Boston Scientific Scimed, Inc. FGE Class II 1997-04-28
K970949 SMITH & NEPHEW MIS INSTRUMENTS Smith & Nephew Endoscopy, Inc. GCJ Class II 1997-04-23
K970969 KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET The Kendal Co. KOB Class II 1997-04-23
K970966 COMFORT CATH CHOICE MALE EXTERNAL CATHETER Sierra Laboratories, Inc. EXJ Class I 1997-04-22
K970764 COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES Comeg Endoscopy OCX Class II 1997-04-22
K964365 RESECTOSCOPE CUTTING LOOP ELECTRODE Omnitech Systems, Inc. FAS Class II 1997-04-22
K970307 MINNOVA PELVIC FLOOR STIMULATION SYSTEM Empi KPI Class II 1997-04-22
K970754 INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP Innerdyne, Inc. GCJ Class II 1997-04-21
K955487 GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS Cobe Renal Care, Inc. KDI Class II 1997-04-18
K970382 VS-100 VIDEO SIGMOIDOSCOPE Welch Allyn, Inc. FAM Class II 1997-04-17
K970602 VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL Hollister, Inc. KPI Class II 1997-04-15
K970369 VISTA MINI CAMERA SYSTEM Oktas GCJ Class II 1997-04-14
K970214 3 DIMENSIONAL VIDEO ENDOSCOPE Oktas GCJ Class II 1997-04-14
K962814 DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER Denver Biomaterials, Inc. KPM Class II 1997-04-14
K970278 MICROVASIVE GOLD PROBE Boston Scientific Corp KNS Class II 1997-04-11
K970563 OLYMPUS NA-10J-1 ASPIRATION NEEDLE Olympus America, Inc. FCG Class II 1997-04-11
K963126 AESOP SYSTEM AND ACCESSORIES Computer Motion, Inc. GCJ Class II 1997-04-07

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