meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
44
Latest Decision
1995-05-26

Clearances · page 66 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K943629 GIP/MEDI-GLOBE PAPILLOTOME Medi-Globe Corp. KNS Class II 1995-05-26
K945262 OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES Optus, Inc. FAJ Class II 1995-05-26
K943935 GIP/MEDI-GLOBE POLYPECTOMY SNARES Medi-Globe Corp. FDI Class II 1995-05-26
K950702 LAPAROSCOPIC CLAMP Applied Medical Resources GCJ Class II 1995-05-25
K951106 SILICONE FOLEY CATHETER Cook Urological, Inc. EZL Class II 1995-05-25
K945622 MCA(TM) 180 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl FJI Class II 1995-05-25
K951945 PROSYS LEG BAG Convatec, A Division of E.R. Squibb & Sons FAQ Class I 1995-05-25
K943559 REMOTE A'LERT Health Sense Intl., Inc. KPN Class II 1995-05-24
K951895 ACCU-BEAM 300W XENON LIGHT SOURCE Tti Medical GCT Class II 1995-05-24
K950862 KARL STORZ ENDOVISION TRICAM, MODEL 20221101 (20221001, PAL FORMAT) COLOR TELEVISION CAMERA FOR ENDOSCOPIC PROCEDURES Karl Storz Imaging, Inc. GCJ Class II 1995-05-24
K951971 XENON LIGHT SOURCE Envision Medical Corp. GCT Class II 1995-05-24
K951995 KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR Karl Storz Endoskop GmbH KNY Class II 1995-05-24
K943558 PRO'TECT Health Sense Intl., Inc. KPN Class II 1995-05-24
K945542 ALTRA FLUX(TM) 170 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl KDI Class II 1995-05-23
K941722 FNA BIOPSY NEEDLE Betta Medical, Inc. FCG Class II 1995-05-22
K935471 FILTRYZER(TM) Toray Industries (America), Inc. FJI Class II 1995-05-19
K945623 MCA(TM) 130 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl FJI Class II 1995-05-18
K945631 155 SCE(TM) HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl FJI Class II 1995-05-18
K945624 MCA(TM) 160 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl FJI Class II 1995-05-18
K945620 ALTRA FLUX(TM) 140 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl KDI Class II 1995-05-18
K951309 STONE DISLODGER, BASKET Boston Scientific Corp FGO Class II 1995-05-17
K951647 WELCH ALLYN HI - LUX ILLUMINATOR Welch Allyn, Inc. FCW Class II 1995-05-17
K951625 KARL STORZ KOH NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT KARL STORZ Endoscopy-America, Inc. GCJ Class II 1995-05-16
K926073 ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBE Surgimark, Inc. FEG Class II 1995-05-15
K924306 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY United States Endoscopy Group, Inc. KNT Class II 1995-05-15
K950753 CHAKOFF ENDOSCOPY (CAMERA TELEVISION ENDOSCOPIC WITHOUT AUDIO Stephen Chakoff, Inc. GCJ Class II 1995-05-15
K951715 ENDO IRRIGATOR 2211, INCLUDING TUBING Richard Wolf Medical Instruments Corp. GCJ Class II 1995-05-12
K950658 INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP: Innerdyne, Inc. GCJ Class II 1995-05-12
K941708 COBE CENTRYSYSTEM CS500 DIALYZER C.G.H. Medical, Inc. FJI Class II 1995-05-12
K951648 MIST ENDOSCOPIC NEEDLES Mist, Inc. FBK Class II 1995-05-12
K950632 INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP Innerdyne, Inc. GCJ Class II 1995-05-12
K945907 KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC ENDOSCOPIC UROLOGY PROCEDURES KARL STORZ Endoscopy-America, Inc. FGC Class II 1995-05-12
K951530 PROSYS URIHESIVE SYSTEM LA Convatec, A Division of E.R. Squibb & Sons EXJ Class I 1995-05-12
K951761 METEL URETERAL BASKET STONE DISLODGER Annex Medical, Inc. FFL Class II 1995-05-11
K945753 FST FIBEROPTIC PRESSURE CONVERTER Fiberoptic Sensor Technlogies, Inc. FEN Class II 1995-05-11
K950974 KARL STORZ ENDOVISION DIGIVIDEO (DIGITAL IMAGE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENDOSCOPIC PROCS Karl Storz Imaging, Inc. FET Class II 1995-05-11
K950975 KARL STORZ ENDOVISION TWINVIDEO (DIGITAL PICTURE-IN-PICTURE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENS Karl Storz Imaging, Inc. FET Class II 1995-05-11
K951535 KARL STORZ ENDOSCOPES, TELESCOPE HOLDERS KARL STORZ Endoscopy-America, Inc. GCJ Class II 1995-05-09
K950562 IMPLANTABLE STAPLE United States Surgical, A Division of Tyco Healthc GCJ Class II 1995-05-09
K950959 TROCAR SUPRAPUBIC, NON-DISPOSABLE TROCAR, DISPOSABLE Miller Instrument, Inc. GCJ Class II 1995-05-09
K950502 CCD ENDOCAM 5501 Richard Wolf Medical Instruments Corp. GCJ Class II 1995-05-04
K940910 FILTRYZER Toray Industries (America), Inc. FJI Class II 1995-05-04
K925469 JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT J.J. Skinner, Inc. FKG Class I 1995-05-03
K945185 CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB) KARL STORZ Endoscopy-America, Inc. FBO Class II 1995-05-03
K951481 MIST ENDOSCOPIC CANNULAS Mist, Inc. GCJ Class II 1995-05-03
K951480 MIST TROCARS Mist, Inc. GCJ Class II 1995-05-03
K925581 BAXTER BIOSTAT 1000 UREA MONITOR Baxter Healthcare Corp KXM Class II 1995-05-03
K951692 MIST ENDOSCOPIC PROBES Mist, Inc. GCJ Class II 1995-05-03
K945191 ENDOSCOPIC ACCESSORY Un-I-Med, Inc. FAS Class II 1995-05-03
K951398 MIST REDUCER SLEEVES Minimally Invasive Surgical Technologies, Inc. GCJ Class II 1995-05-03
K951445 OLYMPUS FD-5 HOT BIOPSY FORCEPS Olympus America, Inc. KGE Class II 1995-05-03
K950784 DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM Advanced Bioresearch Assoc. EYQ Class I 1995-05-03
K951103 SILASTIC BRAND FOLEY CATHETER C.R. Bard, Inc. EZL Class II 1995-04-28
K944385 MD400 A/B/C/D/E/F/G International Purification Systems, Inc. FIP Class II 1995-04-28
K950700 BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA C.R. Bard, Inc. ODD Class II 1995-04-27
K950300 BARD FLEXIBLE TIP URETERAL CATHETER C.R. Bard, Inc. EYB Class II 1995-04-27
K950454 CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER Baxter Healthcare Corp FJI Class II 1995-04-27
K950522 CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER Baxter Healthcare Corp KDI Class II 1995-04-27
K944620 SERIES 400 GASTROENTEROLOGY SYSTEM Marks & Murase FET Class II 1995-04-27
K951488 KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP The Kendal Co. KNY Class II 1995-04-25
K950612 ENDOSCOPES AND ACCESSORIES Storz Instrument Co. GCJ Class II 1995-04-25
K951713 BUTTON LUBRICATOR Fibertech Instruments, Inc. FHX Class II 1995-04-25
K951444 ENDOPATH OPTICAL ACCESS NEEDKLE Ethicon Endo-Surgery, Inc. GCJ Class II 1995-04-25
K951252 KARL STORZ PEDIATRIC PYLORIC SPREADER, PYLOROTOME, ENDOTOME KARL STORZ Endoscopy-America, Inc. GCJ Class II 1995-04-25
K951178 UROLOGICAL CATHETER & ACCESSORIES Deroyal Industries, Inc. FCM Class II 1995-04-21
K951598 PRO-B BIOPSY NEEDLE Promedical , Ltd. FCG Class II 1995-04-21
K945612 MIC NASOGASTRIC-GASTROJEJUNAL FEEDING TUBE Medical Innovations Corp. KNT Class II 1995-04-19
K950726 TSI WILLEN-REICH NEEDLE Tahoe Surgical Instruments P.R., Inc. GCJ Class II 1995-04-18
K950126 ENDOSCOPIC LIGATION DEVICE, LIGATOR HANDLE, LIGATOR CARTRIDGE Advanced Surgical, Inc. GCJ Class II 1995-04-13
K943240 FLEXIFLO SIX ENTERAL NUTRITION PUMP SET Abbott Laboratories KNT Class II 1995-04-13
K945292 TS-700P CONTROL XP ELECTRICAL STIMULATOR Myo/Kinetic Systems, Inc. KPI Class II 1995-04-12
K944759 200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM Fujinon, Inc. FET Class II 1995-04-11
K946358 ENDOSCOPIC BILIARY CATHETER Boston Scientific Corp LQR Class II 1995-04-11
K951387 SYMBIOSIS BIPOLAR SCISSORS Symbiosis Corp. GCJ Class II 1995-04-10
K950908 FST CATH-UD, CATHETER Fiberoptic Sensor Technlogies, Inc. FEN Class II 1995-04-07
K951104 ENDOBOOT United States Endoscopy Group, Inc. OCU Class II 1995-04-06
K950243 TITAN INSUFFLATION NEEDLE Endolap, Inc. GCJ Class II 1995-04-06
K950339 KSEA STEINER ELECTROMECHANIC MORCELLATOR KARL STORZ Endoscopy-America, Inc. GCJ Class II 1995-04-06
K951229 MODIFIED BIOPSY NEEDLE Biopsys Medical, Inc. KNW Class II 1995-04-06
K944614 MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM Biosearch Medical Products, Inc. FDX Class II 1995-04-05
K933200 OLYMPUS PBD STENTS Olympus Corp. FGE Class II 1995-04-05
K950282 KARL STORZ MODIFIED VERESS NEEDLE AND CANNULA KARL STORZ Endoscopy-America, Inc. KOC Class II 1995-04-05
K950982 B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE B. Braun of America, Inc. FCG Class II 1995-04-04
K944309 M.E.R. SURGICAL CO. OMNI INSTRUMENT SYSTEM M.E.R. Surgical Co. GCJ Class II 1995-04-03
K951251 KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE KARL STORZ Endoscopy-America, Inc. GCJ Class II 1995-04-03
K946282 UNIVERSAL URETHRAL CATHETER Louisville Laboratories, Inc. EZC Class II 1995-03-31
K950021 REUSABLE TROCAR WITH SAFETY SLEEVE L.A.S.E.R., Inc. GCJ Class II 1995-03-31
K950016 CART, MODE NUMBER UDS-CART Laborie Medical Tech Corp. FEN Class II 1995-03-30
K950496 SNARE, FLEXIBLE, ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES Boston Scientific Corp FDI Class II 1995-03-30
K950277 INSURG LAPTIE PLUS SUTURE LIGATOR WITH NEEDLE DRIVER Boston Scientific Corp GCJ Class II 1995-03-29
K950434 KARL STORZ FLEXIBLE GRASPING, BIOPSY FORCEPS, STONE BASKETS, DISLODGERS, SCISSORS, INJECTION CANNULAE, CLEANING BRUSHES KARL STORZ Endoscopy-America, Inc. OCZ Class II 1995-03-29
K950985 ZEISS ENDOLIVE STERO ENDOSCOPE Carl Zeiss, Inc. GCJ Class II 1995-03-29
K944765 KARL STORZ INSULATED BIOPSY FORCEPS, GRASPING/DISSECTING FORECPS, FLEXIBLE FORCEPS KARL STORZ Endoscopy-America, Inc. KGE Class II 1995-03-28
K950811 KARL STORZ FIBER OPTIC LIGH CABLES KARL STORZ Endoscopy-America, Inc. GCJ Class II 1995-03-28
K950836 REDFIELD INFRARED COAGULATOR Hogan & Hartson KNS Class II 1995-03-24
K951173 MANUAL SURGICAL INSTRUMENT FOR GENERAL USE United States Surgical, A Division of Tyco Healthc GCJ Class II 1995-03-24
K950344 HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER Acacia Laboratories, Inc. FCM Class II 1995-03-24
K944388 R&D BATTERIES PART NOS. 5116, 5124, 5099, 5100 R & D Batteries, Inc. FCO Class I 1995-03-23
K950690 PROSYS URIHESICE SYSTEM NL Convatec, A Division of E.R. Squibb & Sons EXJ Class I 1995-03-23
K935235 ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY Smith & Nephew Richards, Inc. GCM Class II 1995-03-23

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