meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
40
Latest Decision
1998-02-19

Clearances · page 57 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K974215 VET-CO OTC VACUUM DEVICE/VET-CO CONSTRICTION RING SET Vetco, Inc. LKY Class II 1998-02-19
K980226 MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEM Medical Device Technologies, Inc. KNW Class II 1998-02-18
K980248 ACRI R NEEDLE Gallini U.S., LLC KNW Class II 1998-02-18
K980452 MANAN LIVER BIOPSY KIT Medical Device Technologies, Inc. KNW Class II 1998-02-18
K974336 CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC. J-Lloyd Medical, Inc. GCJ Class II 1998-02-13
K974645 FEMASSIST FLEXIBLE Insight Medical Corp. MNG Class I 1998-02-12
K974541 MODIFIED URETERAL INDWELLING CATHETER/STENT Boston Scientific Corp FAD Class II 1998-02-09
K980191 MANAN BILIARY DRAINAGE CATHETER Medical Device Technologies, Inc. FGE Class II 1998-02-09
K972478 PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES Applied Medical Technologies KNT Class II 1998-02-09
K980211 MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES Manan Medical Products, Inc. KNW Class II 1998-02-06
K980196 MD TECH BIOPSY SET FOR BONE AND BONE MARROW Medical Device Technologies, Inc. KNW Class II 1998-02-03
K972119 MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) Medovations, Inc. FAT Class II 1998-02-02
K974440 IBI Gallini U.S., LLC KNW Class II 1998-01-30
K973516 CAPIOX HEMOCONCENTRATOR Terumo Medical Corp. KDI Class II 1998-01-30
K973814 TRUMP-IT II AND MAGNUM 250 Valley West, Inc. GCJ Class II 1998-01-30
K980005 MANAN D BAG Medical Device Technologies, Inc. EXF Class II 1998-01-30
K980122 MANAN SOFT TISSUE BIOPSY NEEDLES Medical Device Technologies, Inc. KNW Class II 1998-01-30
K972298 ETB TELESCOPE W/WORKING CHANNEL FOR SEPS The Altomec Corp. GCJ Class II 1998-01-30
K973504 UROSURGE UROSTENT Princeton Regulatory Assoc. FAD Class II 1998-01-30
K974391 KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEM Karl Storz Imaging, Inc. GCJ Class II 1998-01-30
K974137 UROMED NEEDLE GRASPER Uromed Corp. OCW Class II 1998-01-30
K974139 LQUET CANNULA/TROCAR SYSTEM Lifequest Endoscopic Technologies, Inc. GCJ Class II 1998-01-28
K974419 RUSCH SIMPLASTIC COUNCILL TIP CATHETER Rusch, Inc. EZL Class II 1998-01-27
K972437 ROSS ENTERAL FEEDING TUBE Ross Products FPD Class II 1998-01-26
K974767 SMITH & NEPHEW DYONICS ARTHOSCOPES/ENDOSCOPES, SMITH & NEPHEW DYONICS LAPAROSCOPES, SNITH & NEPHEW DYONICS HYSTEROSCOPES Endoscopy Division GCJ Class II 1998-01-23
K972025 RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT Radius Intl., Inc. KNT Class II 1998-01-23
K972102 RADIUS PUSH OVER THE GUIDE WIRE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT Radius Intl., Inc. KNT Class II 1998-01-23
K974794 WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY NEEDLE Worldwide Medical Technologies, LLC KNW Class II 1998-01-23
K980068 WORLDWIDE MEDICAL TECHNOLOGIES I TYPE NEEDLE Worldwide Medical Technologies, LLC KNW Class II 1998-01-23
K974168 COOPERSURGICAL INFRARED COAGULATOR Hogan & Hartson KNS Class II 1998-01-23
K971901 RADIUS LOW PROFILE GASTROSTOMY TUBE KIT Radius Intl., Inc. KNT Class II 1998-01-22
K973788 MICROVASIVE LIPTHOTRIPSY PROBES Boston Scientific Corp FFK Class II 1998-01-21
K974312 REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR Telemed Systems, Inc. KNW Class II 1998-01-21
K974018 WILSON-COOK 10 SHOT MULTI-BAND LIGATOR Wilson-Cook Medical, Inc. FHN Class II 1998-01-20
K973046 SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK General Surgical Innovations GCJ Class II 1998-01-16
K971627 SILICONE ANTIBACTERIAL FOLEY CATHETER Rochester Medical Corp. MJC Class II 1998-01-13
K974592 INTERCEPTRE LAPAROSCOPIC INSTRUMENTS Smith & Nephew, Inc. GCJ Class II 1998-01-12
K973891 LAPAROSCOPIC GASTROSTOMY KIT Applied Medical Resources KNT Class II 1998-01-12
K973543 KRONNER LOW PROFILE SCOPE HOLDER Kronner Prototypes, Inc. GCJ Class II 1998-01-12
K970663 CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G) Baxter Healthcare Corp MSF Class II 1998-01-11
K974327 WINGED NEEDLE HOLDER Phx Technologies Corp. FHQ Class I 1998-01-09
K970888 IOTEC TROCAR AND FLEXIBLE CANNULA Iotec Industries GCJ Class II 1998-01-09
K980004 MANAN GENERAL PURPOSE INTRODUCER NEEDLE Medical Device Technologies, Inc. KNW Class II 1998-01-09
K974814 MANAN(TM) SUPER-CORE BIOPSY NEEDLES Medical Device Technologies, Inc. KNW Class II 1998-01-09
K974470 VTU-E VACUUM ERECTION SYSTEM Encore, Inc. LKY Class II 1998-01-09
K974815 MANAN(TM) INTRODUCER SHEATH/NEEDLE Medical Device Technologies, Inc. FGE Class II 1998-01-09
K973152 GALLINI ABS DEVICE Gallini U.S., LLC KNW Class II 1998-01-09
K974446 MANAN AUTOMATIC CUTTING NEEDLE Manan Medical Products, Inc. KNW Class II 1998-01-08
K972184 RUSCH BRILLANT SILICONE FOLEY CATHETER Rusch Intl. EZL Class II 1998-01-08
K974766 MANAN TECHNA-CUT ASPIRATION NEEDLE Medical Device Technologies, Inc. KNW Class II 1998-01-08
K971442 HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,MED-38,MED-T-10,MED-T-25,MED-T-5 Humed, Inc. KPN Class II 1998-01-08
K974366 KSEA PLASTIC TROCARS Karl Storz Endoscopy GCJ Class II 1998-01-08
K974637 ELECTRODES/PROBES/DEVICES Ximed/Prosure/Injectx FAS Class II 1998-01-07
K970648 PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) Renal Systems, Inc. MSF Class II 1998-01-05
K973794 S-57 VIDEO IMAGING SYSTEM Sopro GCJ Class II 1998-01-02
K973796 S-41 &41S VIDEO IMAGING SYSTEM Sopro GCJ Class II 1998-01-02
K973795 S-52 ELECTRONIC VIDEO LAPAROSCOPE Sopro GCJ Class II 1998-01-02
K974048 INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER Hollister, Inc. KPI Class II 1997-12-23
K974516 ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE Endolap, Inc. FAS Class II 1997-12-22
K974515 ENDOLAP RESECTOSCOPE ROLLER ELECTRODE Endolap, Inc. FAS Class II 1997-12-22
K970708 CLIRANS T-SERIES HOLLOW FIBER DIALYZERS Terumo Medical Corp. FJI Class II 1997-12-19
K974127 HYDRA METER Automata Instrumentation, Inc. FIP Class II 1997-12-19
K972699 AESOP 3000 SYSTEM AND ACCESSORIES Computer Motion, Inc. GCJ Class II 1997-12-19
K974300 TELEMED SYSTEMS RETRIEVAL BASKET Telemed Systems, Inc. OCZ Class II 1997-12-19
K973893 AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE Applied Medical Technologies KNT Class II 1997-12-19
K974042 AMSURE CLEANSING ENEMA SET Amsino Intl., Inc. FCE Class I 1997-12-19
K973291 DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES Dynamic Technology Corp. FJI Class II 1997-12-19
K974454 CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004 Tucson Medical Corp. OCT Class II 1997-12-18
K974164 SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE Medical Device Consultants, Inc. FFK Class II 1997-12-18
K970465 BOUSER'S URINAL General Polymers EXJ Class I 1997-12-18
K973008 COURIER ST BALLOON DILATATION CATHETER Boston Scientific Corp FGE Class II 1997-12-15
K972470 CRIT-LINE MONITOR (CLMIII) In-Line Diagnostics Corp. MQS Class II 1997-12-11
K972887 MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG Medline Industries, Inc. KNX Class II 1997-12-11
K972979 SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM Smith & Nephew, Inc. FBO Class II 1997-12-11
K972280 GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES Wilson Greatbatch Technologies, Inc. GCJ Class II 1997-12-11
K974158 ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY Ortho Development Corp. KNW Class II 1997-12-09
K972496 PENCIL-GRIP FNA SYRINGE HOLDER AND EFFORTLESS NEEDLE REMOVER Tao & Tao Technologyt, Inc. KNW Class II 1997-12-09
K973436 VISTA HEAD MOUNTED DISPLAY Vista Medical Technologies, Inc. GCJ Class II 1997-12-09
K973826 SPHINCTEROTOME Boston Scientific Corp KNS Class II 1997-12-05
K973798 S-357 VIDEO IMAGING SYSTEM Sopro FET Class II 1997-12-03
K973415 CURVILINEAR SUTURE PLACEMENT SYSTEM Laurus Medical Corp. GCJ Class II 1997-12-02
K973611 SPECTRASCIENCE REUSABLE BIOPSY FORCEPS Spectrascience, Inc. FCL Class I 1997-12-02
K973313 INNOVASIVE DEVICES Y-KNOT SUTURE CLIP Innovasive Devices, Inc. OCW Class II 1997-12-01
K973496 THE AUTO SUTURE* MIBB** SYSTEM United States Surgical, A Division of Tyco Healthc KNW Class II 1997-12-01
K973249 ENDOASSIST Armstrong Healthcare , Ltd. GCJ Class II 1997-11-26
K973366 COBRA HAND PIECE Vidamed, Inc. KNS Class II 1997-11-26
K972206 NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS Nipro Medical Corp. KOC Class II 1997-11-26
K964539 PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF, F800-F802, RO SECURA, REVERSE OSMOSIS SYST Zyzatech Water Systems, Inc. FIP Class II 1997-11-26
K972066 BELZER-MPS Trans-Med Corp. KDN Class II 1997-11-26
K973229 D.O.R.C. HEXON ILLUMINATION SYSTEM Dutch Ophthalmic USA, Inc. MPA Class II 1997-11-25
K963933 PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER Baxter Healthcare Corp FJI Class II 1997-11-24
K973359 PANOVIEW PLUS TELESCOPE, 3.5MM, O,WL 300MM/25,WL 300MM/0,WL 180MM Richard Wolf Medical Instruments Corp. GCJ Class II 1997-11-24
K973205 WILSON-COOK STRICTURE MEASURING CATHETER Wilson-Cook Medical, Inc. ODD Class II 1997-11-24
K973252 KARL STORZ DIRECT COUPLED CAMERA HEAD Karl Storz Imaging, Inc. FET Class II 1997-11-24
K973558 VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) Ultracell Medical Technologies, Inc. FEB Class II 1997-11-24
K972582 URESIL GUIDEWIRE Uresil Corp. FGE Class II 1997-11-21
K973232 OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT Olympus Winter & Ibe GmbH GCJ Class II 1997-11-21
K971354 KNOTT NG TUBE Michael M. Knott, M.D. FEG Class II 1997-11-19
K970674 G.E.M. WATER SYSTEMS, INTERNATIONAL G.E.M. Water Systems FIN Class II 1997-11-19
K973293 SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR Vaughan Weeks MPA Class II 1997-11-18

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