meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
47
Latest Decision
1992-01-10

Clearances · page 80 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K914008 PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P Pentax Precision Instrument Corp. FAJ Class II 1992-01-10
K914106 PENTAX URETERORENOFIBERSCOPE, MODEL FUR-10P Pentax Precision Instrument Corp. FGB Class II 1992-01-10
K914978 OXYGUARD Stantex Pty , Ltd. MNK Class I 1992-01-10
K914280 ECHOSIGHT STENT SET Cook Urological, Inc. FAD Class II 1992-01-09
K914919 SMITH & NEPHEW DYONICS LAPAROSCOPY SYSTEM Smith & Nephew Dyonics, Inc. GCJ Class II 1992-01-09
K914516 9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION Northgate Technologies, Inc. FFK Class II 1992-01-07
K904939 FLEXIBLE AND RIGID URETEROTOME SYSTEM Olympus Corp. EZO Class II 1992-01-07
K914997 ASP-IRRATOR Conmedcorp GCJ Class II 1992-01-07
K914732 CORE MEDICAL BIOPSY NEEDLE Core Medical, Inc. FCG Class II 1992-01-07
K914882 WILTEK BALLOON CHOLANGIOGRAPHY CATHETER Wiltek Medical, Inc. FGE Class II 1992-01-07
K914515 3 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION Northgate Technologies, Inc. FFK Class II 1992-01-07
K914881 WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER Wiltek Medical, Inc. FGE Class II 1992-01-07
K914891 PULLER OPTION FOR ETUDE(TM) Dantec Medical, Inc. FAP Class II 1992-01-07
K914514 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION Northgate Technologies, Inc. FFK Class II 1992-01-06
K914497 BIOPSY FORCEPS Surgitek Medical Engineering Corp. FCL Class I 1992-01-03
K914482 STOMA MEASURING DEVICE Biosearch Medical Products, Inc. FPD Class II 1991-12-27
K913477 APEX(TM) PROSTATIC BALLOON DILATION CATHETER Peripheral Systems Group KOE Class II 1991-12-27
K913129 ANGIOLAZ ANGIOSCOPE CATHETER Angiolaz, Inc. LYK Class II 1991-12-27
K913387 DIGITRAPPER MARK III Synectics-Dantec FFT Class I 1991-12-27
K911730 SURGICAL OBTURATOR WITH SEAL Applied Vascular Devices, Inc. GCJ Class II 1991-12-23
K914617 CATHETER, URETERAL DILATOR Boston Scientific Corp EZN Class II 1991-12-20
K913810 HOLMED HAND HELD INSTRUMENTS Performance Surgical Instruments Corp. GCJ Class II 1991-12-19
K914530 ICAN GT DRAINAGE BAG Icn Pharmaceuticals, Inc. FRQ Class II 1991-12-18
K905026 DUAL FLEX NON-LATEX Mmi, Inc. FGD Class II 1991-12-18
K913954 MARLOW/REDDICK LAPAROSCOPIC NEEDLE HOLDERS Marlo Surgical Technology GCJ Class II 1991-12-18
K905552 LAPAROLITH Baxter Healthcare Corp LQC Class II 1991-12-17
K912919 MENTOR INFUSION LINE Mentor Corp. KNY Class II 1991-12-13
K914782 SUCTION/IRRIGATION PROBE O.R. Concepts, Inc. GCJ Class II 1991-12-09
K912701 DANTEC MENUET Dantec Medical, Inc. FAP Class II 1991-12-09
K914505 STONE BASKET Surgitek Medical Engineering Corp. FFL Class II 1991-12-09
K914781 SUCTION/IRRIGATION KITTNER O.R. Concepts, Inc. GCJ Class II 1991-12-09
K914503 GRASPING FORCEPS Surgitek Medical Engineering Corp. OCZ Class II 1991-12-05
K914496 SCLEROTHERAPY NEEDLE Surgitek Medical Engineering Corp. FBK Class II 1991-12-05
K914549 ETHICON ABSORBABLE SUTURE CLIP AND APPLIER ETHICON, Inc. GCJ Class II 1991-12-04
K912451 URODYNAMIC RECTAL BALLOON Cook Urological, Inc. FAP Class II 1991-12-02
K914470 PNEUMO-SEAL(TM) Edward Weck, Inc. GCJ Class II 1991-11-29
K913955 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION Northgate Technologies, Inc. FFK Class II 1991-11-29
K914277 WALLSTENT(R) TRANS BILIARY ENDO W/UNISTEP DELIV SY Schneider U.S. Stent Div. FGE Class II 1991-11-29
K914212 BARD SINGULAR BIOPSY FORCEPS C.R. Bard, Inc. FCL Class I 1991-11-27
K914426 ENTREE NEEDLE Core Dynamics, Inc. FHO Class II 1991-11-27
K904798 SUPRAPUBIC FLOW CONTROLLER Olympus Corp. KOB Class II 1991-11-22
K914967 SHARP ENDOKNOT PUSHER Sharpe Endosurgical Corp. GCJ Class II 1991-11-22
K914211 CATH CONTROL Highpoint Medical Corp. KNY Class II 1991-11-22
K913932 PERCUTANEOUS DILATOR WITH SHEATH Interventional Therapeutics Corp. FGE Class II 1991-11-22
K914547 LAPAROBAG(TM) TISSUE RETRIEVAL SYSTEM Baxter Healthcare Corp GCJ Class II 1991-11-22
K914526 DAVOL ENDO-FLO SUCT/IRRI PROBE (FOR GEN SURGERY) Davol, Inc. GCJ Class II 1991-11-22
K912575 EXTERNAL GASTROSTOMY TUBE RETAINER Sandoz Nutrition FPD Class II 1991-11-21
K913763 INTERPRET(TM) CATHETER LINEAR TRANSLATOR Intertherapy, Inc. LYK Class II 1991-11-20
K914358 ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP Hobbs Medical, Inc. EYB Class II 1991-11-19
K913928 SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT Surgitek Medical Engineering Corp. FAD Class II 1991-11-19
K912247 UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORY Laser Engineering, Inc. GCJ Class II 1991-11-13
K913816 ORIGINEEDLE, MODIFICATION Origin Medsystems, Inc. FHO Class II 1991-11-08
K913786 FLEXIFLO OVER-THE-GUIDEWIRE GAST KIT W/CR-BAR BUMP Abbott Laboratories KNT Class II 1991-11-05
K913098 APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501 Dlp, Inc. KNW Class II 1991-11-05
K911587 K-SOL(TM) Alcon Laboratories KDN Class II 1991-11-01
K913950 DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY Althin Medical AB an Affiliate of Baxter Intl KDI Class II 1991-11-01
K913526 SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS Althin Medical AB an Affiliate of Baxter Intl FJK Class II 1991-11-01
K913881 ENDOSTAT ELECTROSURGICAL UNIT Medical and Scientific Enterprises, Inc. KNS Class II 1991-11-01
K913999 NEZHAT DORSEY SUCTION PROBE W/INNER IRRIGA TUBE American Surgical Instruments Corp. GCJ Class II 1991-11-01
K913620 ENEMA KIT York County Blind Center FCE Class I 1991-11-01
K911315 EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT Baxter Healthcare Corp KOC Class II 1991-10-30
K914377 TROCAR O.R. Concepts, Inc. GCJ Class II 1991-10-30
K912331 URS-HYDRO-DILATOR MODEL NUMBER 2164.00 Richard Wolf Medical Instruments Corp. EZN Class II 1991-10-30
K914120 SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT Conmedcorp GCI Class II 1991-10-30
K913762 MONOSCOPY(TM) BRAND, ENDOBAG Dexide, Inc. GCJ Class II 1991-10-28
K914098 LAPAROSCOPIC MINI-DISSECTOR/RIGHT ANGLE RETRACTOR Surgical Innovations Corp. GCJ Class II 1991-10-28
K914466 COX DISPOSABLE CYTOLOGY BRUSHES Cox Medical Ent., Inc. FDX Class II 1991-10-25
K913073 DOBBHOFF(R) PERCUTANEOUS TRANSHEPAT BILIARY STENT Biosearch Medical Products, Inc. FGE Class II 1991-10-25
K914442 COX DISPOSABLE ENDOSCOPE CLEANING BRUSH Cox Medical Ent., Inc. FEB Class II 1991-10-25
K913587 JTECH 50 SERIES CUTTING LOOP J-Tech, Inc. FJL Class II 1991-10-23
K911364 SPOON FORCEPS, 11MM Northgate Technologies, Inc. LQC Class II 1991-10-23
K912492 EVACUATION/IRRIGATION/ELECROSURGICAL DEVICE ETHICON, Inc. GCJ Class II 1991-10-21
K912933 MEDICAM LAPAROSCOPY ENDOSCOPES Kirschner Medical Corp. GCJ Class II 1991-10-15
K912344 MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS Dacomed Corp. FAE Class II 1991-10-11
K912265 MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000 Medical Laser, Inc. FED Class II 1991-10-10
K914203 LAPAROSCOPIC BALLOON RETRACTOR Origin Medsystems, Inc. GCJ Class II 1991-10-09
K913113 FST CATH-UD CATHETER, MODIFICATION Fiberoptic Sensor Technlogies, Inc. FEN Class II 1991-10-09
K913721 FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM Fiberoptic Sensor Technlogies, Inc. FEN Class II 1991-10-08
K913586 MARLOW VERRES NEEDLES Marlo Surgical Technology GCT Class II 1991-10-08
K913841 2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH Endovations FGE Class II 1991-10-08
K900623 ZIMMON ESOPHAGO-GASTRIC BALLOON TAMPONADE DEVICE Wilson-Cook Medical, Inc. KNT Class II 1991-10-07
K913883 COX DISPOSABLE BIOPSY FORCEP Cox Medical Ent., Inc. FCL Class I 1991-10-05
K913524 SILICONE MALE EXTERNAL CATHETER Mentor Corp. EXJ Class I 1991-10-04
K913294 SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT Surgitek Medical Engineering Corp. GCA Class II 1991-10-04
K913991 GRASPER, RATCHETED (5MM X 30CM) Northgate Technologies, Inc. GCJ Class II 1991-10-04
K913603 FIBRETWINS Oral-B Laboratories KNT Class II 1991-09-30
K913248 CYTOLOGY BRUSH Annex Medical, Inc. FDX Class II 1991-09-30
K913469 ENDOPATH DISPOSABLE ENDOSCOPIC MULTIFEED STAPLER ETHICON, Inc. GCJ Class II 1991-09-30
K912447 SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200 Medical Laser, Inc. FET Class II 1991-09-27
K911630 LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER WITH BALLOON Baxter Healthcare Corp FGE Class II 1991-09-27
K913483 MINNILERT(R) PRESSURE MONITOR Minntech Corp. KOC Class II 1991-09-27
K912973 ENDOSCOPE SUTURE & CARRIER United States Surgical, A Division of Tyco Healthc GCJ Class II 1991-09-27
K912060 MENTOR BLACK LIGHT INJECTION STENT SET Mentor Corp. FAD Class II 1991-09-27
K913500 CHERRY SPONGE O.R. Concepts, Inc. GCJ Class II 1991-09-25
K912839 LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE Baxter Healthcare Corp FBW Class I 1991-09-25
K912288 WILTEK STANDARD CHOLANGIOGRAPHY CATHETER Wiltek Medical, Inc. FGE Class II 1991-09-23
K912122 CHOLANGIOGRAPHY CATHETER Wiltek Medical, Inc. FGE Class II 1991-09-23
K912972 FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEEDING TUBE Abbott Laboratories FPD Class II 1991-09-23
K913142 BODEN WHEELCHAIR DRAINAGE SYSTEM Mno Medical Products KNX Class II 1991-09-23
K913323 ETUDE (MODEL NUMBERS 24A05 & 24A06) Dantec Medical, Inc. FAP Class II 1991-09-23

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