meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
62
Latest Decision
1997-04-03

Clearances · page 60 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K963330 URODYNAMIC ANALYSIS MODULE Synectics Medical, Inc. FAP Class II 1997-04-03
K963855 12 URETEROSCOPES/URETERO-RENOSCOPES Richard Wolf Medical Instruments Corp. FGB Class II 1997-04-03
K970308 MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE Mentor Urology, Inc. FHA Class I 1997-04-02
K970217 VISTA ILLUMINATION SYSTEM Vista Medical Technologies, Inc. FFS Class II 1997-04-02
K970121 STONE DISLODGER, BASKET Boston Scientific Corp FGO Class II 1997-04-02
K964555 VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S) Vitrotec, Inc. MPA Class II 1997-03-31
K971057 COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM Cogent Light Technologies, Inc. GCT Class II 1997-03-28
K970053 ULTRATOMERX Boston Scientific Corp KNS Class II 1997-03-28
K970565 MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME) Biopsys Medical, Inc. KNW Class II 1997-03-28
K963051 ERCP CANNULA United States Endoscopy Group, Inc. ODD Class II 1997-03-28
K970788 PNEUMO-MATIC INSUFFLATION NEEDLE Apple Medical Corp. FHO Class II 1997-03-27
K970052 EXTRACTORRX Boston Scientific Corp FGE Class II 1997-03-25
K963203 BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT Baxter Healthcare Corp KDI Class II 1997-03-25
K970994 CORE AND COIL ASSEMBLY GUIDEWIRE Lake Region Mfg., Inc. EZB Class I 1997-03-25
K970356 IRRIGATION/ASPIRATION POLYPECTOMY United States Endoscopy Group, Inc. FDI Class II 1997-03-25
K964690 LIBERTY VALVE Cleveland Medical Devices, Inc. KNX Class II 1997-03-21
K964522 ELLIPSE 4 Andromeda Medizinische Systeme GmbH FEN Class II 1997-03-21
K963813 SURE CORE BIOPSY KIT Interventional Concepts, Inc. KNW Class II 1997-03-20
K970041 ASCEND BALLOON DAILATION CATHETER Cook Urological, Inc. EZN Class II 1997-03-19
K970489 COMEG ENDOSCOPY GRASPING FORCEPS Comeg Endoscopy FFL Class II 1997-03-19
K965093 OMNITECH RESECTOSCOPE ROLLER ELECTRODE Omnitech Systems, Inc. FAS Class II 1997-03-19
K953996 NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS NIKKISO CO., LTD. KDI Class II 1997-03-19
K964745 AMSINO URINARY DRAINAGE BAG Amsino Intl., Inc. KNX Class II 1997-03-18
K963446 KENDALL DUAL LUMEN CATHETER Kendall Healthcare Products Co. Div.Of Tyco Health MPB Class II 1997-03-18
K965087 COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000) Sandoz Nutrition KNT Class II 1997-03-18
K950017 FLEXIFLO FLOCATOR SMALL BOWEL FEEDING SYSTEM Ross Products KNT Class II 1997-03-14
K970704 PERSONAL CATHETER Rochester Medical Corp. GBM Class II 1997-03-13
K961986 MANAN D BAG Manan Medical Products, Inc. EXF Class II 1997-03-13
K961343 MEDVISION PERSONAL MONITOR Medvision, Inc. GCJ Class II 1997-03-13
K970598 INTEGRATED VISUALIZATION SYSTEM Urohealth, Inc. FCW Class II 1997-03-12
K970372 GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS Precision Endoscopy of America, Inc. FDF Class II 1997-03-11
K970427 KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE Karl Storz Endoscopy FGB Class II 1997-03-11
K963894 SMARTGUIDE Ferguson Medical FCG Class II 1997-03-11
K964589 FLEXILOG 3000 Oakfield Instruments, Ltd. KLA Class II 1997-03-04
K965176 PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS Pilling Weck Group OCZ Class II 1997-03-04
K965229 IMAGER TORQUE CATHETER Boston Scientific Corp KOD Class II 1997-03-04
K954676 NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS Nissho Corp. KOC Class II 1997-03-04
K964871 BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS Biosearch Medical Products, Inc. FEB Class II 1997-03-03
K964930 STRYKER SAPHENOUS VEIN HARVEST SCOPE Stryker Endoscopy GCJ Class II 1997-02-28
K964780 BARD DIRECTOR GUIDEWIRE (000560) C.R. Bard, Inc. OCY Class II 1997-02-26
K965118 ENDOCARE MONOPOLAR ELECTRODE Endocare, Inc. FAS Class II 1997-02-25
K970443 HOLLISTER RETRACTED PENIS POUCH Hollister, Inc. EXI Class I 1997-02-25
K962850 TUM-E-VAC Ethox Corp. KDH Class II 1997-02-21
K964037 FLEXIBLE CYSTOSCOPE Applied Fiberoptics, Inc. FAJ Class II 1997-02-20
K964061 GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD) W. L. Gore & Associates, Inc. LYK Class II 1997-02-20
K970110 BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019) Bard Medical Div. ODC Class II 1997-02-19
K962702 SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULA General Surgical Innovations GCJ Class II 1997-02-19
K964171 VASOVIEW BALLOON DISSECTION SYSTEM Origin Medsystems, Inc. GCJ Class II 1997-02-14
K964955 FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING Flexmedics OCY Class II 1997-02-14
K964079 SPEEDBAND MULTIPLE BAND LIGATOR Boston Scientific Corp FHN Class II 1997-02-13
K963285 EMS SWISS LITHOCLAST LITHOTRIPTER Electro Medical Systems SA FFK Class II 1997-02-13
K963115 TROCAR CANNULA United States Surgical, A Division of Tyco Healthc GCJ Class II 1997-02-12
K964561 ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA Bioenterics Corp. FDG Class I 1997-02-11
K960817 HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2) Transonic Systems, Inc. MQS Class II 1997-02-11
K946279 PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) Cobe Renal Care, Inc. KDI Class II 1997-02-10
K964526 LIBERTY RECTAL PELVIC FLOOR EXERCISER Utah Medical Products, Inc. KPI Class II 1997-02-10
K970054 TANDEMRX Boston Scientific Corp GCJ Class II 1997-02-10
K964672 SUTURE APPLICATOR Laurus Medical Group GCJ Class II 1997-02-07
K970021 RUSCH SUPRAPUBIC TRAY Rusch, Inc. KOB Class II 1997-02-07
K964899 KENDALL CURITY URETERAL CATHETER Kendall Healthcare Products Co. Div.Of Tyco Health EYB Class II 1997-02-07
K963023 ULTRASOUND GASTROSCOPE GF TYPE UM30P Olympus America, Inc. FDS Class II 1997-02-07
K954003 COBE HEMODYNAMIC RECIRCULATION MONITOR Cobe Renal Care, Inc. MQS Class II 1997-02-06
K962653 MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP ELECTRODE KIT AND COAGULATING ELECTRODE KIT Microgyn Corp. FAS Class II 1997-02-04
K964892 FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) Gynecare Innovation Center FJL Class II 1997-02-04
K964575 SYMPACATH HYDROGEL COATED FOLEY Rusch Intl. EZL Class II 1997-02-04
K964041 CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS Robert R. Stevens KOC Class II 1997-01-30
K961346 PH ANALYSIS MODULE Synectics-Dantec FFT Class I 1997-01-29
K961897 WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLE Wilson-Cook Medical, Inc. FCG Class II 1997-01-29
K970056 SOLOS, CIDEO CAMERA REPLACEMENT CABLE, 800/900 SERIES Woodbine Optical Corp. GCJ Class II 1997-01-28
K965067 DILATION CATHETER, BALLOON Boston Scientific Corp GBM Class II 1997-01-28
K964482 FLEXIBLE URETEROSCOPE Applied Fiberoptics, Inc. FGB Class II 1997-01-24
K964937 A LITHOTRIPTER-COMPATIBLE BASKET Boston Scientific Corp LQC Class II 1997-01-24
K964577 INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL VAGINAL ELECTRODE(199205) Empi KPI Class II 1997-01-24
K964586 PRESCOTT'S LIGHT SOURCE MODEL NO. II-150 Iba/Griffith FCW Class II 1997-01-17
K964258 INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PERFORATING VINS ESDP, MODEL 8781 Richard Wolf Medical Instruments Corp. GCJ Class II 1997-01-16
K964580 CAP-AID (IMPROVED) Nebel, Inc. FHA Class I 1997-01-10
K963950 BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE Bioderm, Inc. EXI Class I 1997-01-10
K955384 DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION Althin Medical AB an Affiliate of Baxter Intl KDI Class II 1997-01-10
K963760 NON-SHIELDED SURGICAL TROCAR AND SLEEVE Ethicon Endo-Surgery, Inc. GCJ Class II 1997-01-08
K963919 LSI VIDEOSCOPIC DISPLAY SYSTEM Lsi Solutions GCJ Class II 1997-01-08
K965037 CELL RECOVERY SYSTEM Medical Device Technologies, Inc. FDX Class II 1997-01-08
K964777 TZ Gallini Intl., Inc. KNW Class II 1997-01-03
K964326 VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM Vision-Sciences, Inc. FAM Class II 1997-01-03
K963184 OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM Olympus America, Inc. GCJ Class II 1996-12-31
K964120 INJECTO FLUSH Robert J. Jynch, Jr. FCL Class I 1996-12-30
K962309 ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS Althin Medical AB an Affiliate of Baxter Intl FJI Class II 1996-12-27
K964196 CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00) Northgate Technologies, Inc. OCX Class II 1996-12-23
K962474 OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) Olympus America, Inc. FBO Class II 1996-12-20
K963825 AUTO SUTURE* ABBI* SYSTEM United States Surgical, A Division of Tyco Healthc KNW Class II 1996-12-20
K963417 VITLITE (TR7700) Escalon Trek Medical MPA Class II 1996-12-20
K962538 BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06) C.R. Bard, Inc. FAS Class II 1996-12-17
K963993 RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET Rusch, Inc. FCM Class II 1996-12-17
K964100 VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100 Vision-Sciences, Inc. FAM Class II 1996-12-16
K964111 LITHOVAC SUCTION/ASPIRATION PROBE Electro Medical Systems SA KQT Class II 1996-12-16
K962212 KARL STORZ FRIMBERGER VARIOGUIDE KARL STORZ Endoscopy-America, Inc. FDT Class II 1996-12-13
K963849 MANAN D BAG Manan Medical Products, Inc. EXF Class II 1996-12-13
K964173 C-MOUNT OBJECTIVE LENS F = 17 MM, STEAM-STERILIZABLE: MODEL 85 261.172, C-MOUNT OBJECTIVE LENS F = 21 MM, STEAM-STERILIZ Richard Wolf Medical Instruments Corp. FET Class II 1996-12-13
K964123 REUSABLE TROCAR WITH SLEEVE (COMMON) Pilling Weck Group GCJ Class II 1996-12-12
K963691 COURIER BALLOON DILATATION CATHETER Boston Scientific Corp FGE Class II 1996-12-12
K950719 OES UROLOGY Olympus America, Inc. EZO Class II 1996-12-11

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