meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
47
Latest Decision
1995-02-07

Clearances · page 68 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K943879 RESECTOSCOPE ELECTRO CAUTERY CUTTING LOOP American Urologicals, Inc. FAS Class II 1995-02-07
K950125 KARL STORZ BOUGIES AND DILATORS KARL STORZ Endoscopy-America, Inc. FAX Class I 1995-02-07
K945567 QC CAP Medionics International, Inc. KDJ Class II 1995-02-07
K946330 KARL STORTZ PIVOT ARM LAPAROSCOPE SLEEVE, ENDO-RETRACTOR KARL STORZ Endoscopy-America, Inc. GCJ Class II 1995-02-06
K950214 ABDOMINAL WALL RETRACTOR Omni-Tract Surgical, Div. Minn. Scientific, Inc. GCJ Class II 1995-02-06
K943895 VISION SYSTEM COLONSCOPE Vision-Sciences, Inc. FDF Class II 1995-02-03
K950286 SYMBIOSIS BIPOLAR SCISSORS Symbiosis Corp. GCJ Class II 1995-02-03
K945921 ECHO STAR NEEDLE SET Ideamatrix FCG Class II 1995-02-01
K950231 LAPAROSCOPE AND ACCESSORIES FOR GENERAL SURGERY Olympus America, Inc. GCJ Class II 1995-02-01
K950170 CONMED SOFT-TIP SUCTION/IRRIGATION CANNULAE Conmedcorp GCJ Class II 1995-02-01
K945491 SERIM(TM) BICARB PH REAGENT STRIPS Serim Research Corp. MNV Class II 1995-02-01
K930510 RADIUS ENTERAL FEEDING TUBE Radius Intl., Inc. BSS Class II 1995-02-01
K950278 MINI LAPAROSCOPY FOR GENERAL SURGERY Olympus America, Inc. GCJ Class II 1995-02-01
K950267 URETHRAL SUTURE GUIDE Applied Medical Resources KOA Class I 1995-01-31
K943851 ALL SILICONE INTERMITTENT CATHETER Rochester Medical Corp. GBM Class II 1995-01-31
K946239 ENDOXFLEX 5000 Michael A Clark GCJ Class II 1995-01-30
K941803 PRISM MEDICAL CUSTOM DIALYSIS KIT Medical Device Support Services KOC Class II 1995-01-30
K945764 HIGH TEMPERATURE CAUTERY ELONGATED FINE TIP Aaron Medical Industries KNS Class II 1995-01-30
K935781 ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAY Sherwood Medical Co. FEG Class II 1995-01-27
K946213 KSEA STEINER ELECTROMECHANIC MORCELLATORT KARL STORZ Endoscopy-America, Inc. GCJ Class II 1995-01-27
K945520 HEMOCLIP ECOSYSTEM Pilling Weck, Inc. GCJ Class II 1995-01-27
K950063 WGL ENDOSCOPIC GRASPER* Wilson Greatbatch Technologies, Inc. GCJ Class II 1995-01-27
K946241 ENDOPATH(R) TRISTAR(TM) DISSECTOR AND TISSUE MANIPULATOR Ethicon Endo-Surgery, Inc. GCJ Class II 1995-01-27
K945394 INNOVATIVE SURGICAL(R) MANGUM KNOT PUSHER Innovative Surgical, Inc. GCJ Class II 1995-01-27
K946171 VIDEO ENDOSCOPE SYSTEM WITH ZOOM Oktas GCJ Class II 1995-01-26
K946263 BRIMFIELD PRECISION GRASPER/DISSECTOR Springfield Surgical Instruments GCJ Class II 1995-01-26
K933818 GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER C.G.H. Medical, Inc. KDI Class II 1995-01-25
K945576 MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R) Meadox Medicals, Div. Boston Scientific Corp. EZN Class II 1995-01-24
K935094 BALLOON DILATION CATHETER Wilson-Cook Medical, Inc. FGE Class II 1995-01-24
K934434 CYBERRX MODEL 7200 Cybermed Control Systems, Inc. FFT Class I 1995-01-24
K943835 PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID Orion Life Systems, Inc. KNY Class II 1995-01-24
K944220 WILSON COOK MULTIPLE BAND LIGATOR Wilson-Cook Medical, Inc. MND Class II 1995-01-24
K946238 SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS Symbiosis Corp. FCL Class I 1995-01-20
K941911 INNOVA PELVIC FLOOR STIMULATION SYSTEM Empi KPI Class II 1995-01-20
K945202 ENDOPATH ENDOSCOPIC RELOADABLE LINEAR CUTTER WITH SAFETY LOC-OUT AND RELOADING UNIT Ethicon Endo-Surgery, Inc. OCW Class II 1995-01-19
K935958 CRIT-LINE BLOOD CHAMBER WITH E-BEAM In-Line Diagnostics Corp. KOC Class II 1995-01-19
K950005 TROCAR CANNULA STABILIZER Advanced Surgical, Inc. GCJ Class II 1995-01-18
K945170 QUIK-STITCH Coral Medical, Inc. GCJ Class II 1995-01-18
K941222 OPEN LAPAROSCOPY TROCAR CONE SYSTEM Richard Wolf Medical Instruments Corp. GCJ Class II 1995-01-18
K946164 KS SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC GENERAL ENDOSPOCIC AND LAPAROSCOPIC SURGICAL PROS KARL STORZ Endoscopy-America, Inc. GCJ Class II 1995-01-18
K945545 ACCESS SURGICAL INT'L THORACIC ENDOSCOPIC SURGICAL INSTRUMENTS Access Surgical Intl., Inc. GCJ Class II 1995-01-12
K944882 IRRIGATION TRAY Clinical Resources, Inc. EYN Class II 1995-01-12
K921478 GUARDPORT Health Improvement Assoc. KNT Class II 1995-01-11
K925406 BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEM Schneider Intl., Ltd. FGE Class II 1995-01-11
K926567 BAXTER CA DIALYZER Baxter Healthcare Corp FJI Class II 1995-01-11
K922216 FLEXIFLO TUBE PLACEMENT VERIFIER Abbott Laboratories KNT Class II 1995-01-09
K943614 A.W.E.L. Medi-Flex GCJ Class II 1995-01-04
K945732 FOG FREE Tonn Chemical Co., Inc. OCT Class II 1995-01-04
K944386 R&D BATTERIES PART NOS. 5354 AND 5150 R & D Batteries, Inc. FCO Class I 1994-12-30
K944294 R&D BATTERIES, INC. PART NUMBERS 5162, 5040, 5237, AND 5102 R & D Batteries, Inc. FCO Class I 1994-12-30
K943675 ENTERAL DELIVERY SETS WITH HYDRATION PORT Clintec Technologies, Inc. KNT Class II 1994-12-30
K935688 AN-10S ANDERSEN TUBE WITH STYLET H.W. Andersen Products, Inc. BSS Class II 1994-12-30
K921682 ZINETICS AMC Zinetics Medical, Inc. FFX Class II 1994-12-29
K945867 R&D PART 5518, 5306, 5315 AND 5457 R & D Batteries, Inc. FCO Class I 1994-12-29
K924850 VANSONNENBERG GASTROSTOMY CATHETER Boston Scientific Corp KNT Class II 1994-12-29
K931595 REVERSE OSMOSIS EQUIPMENT FOR WATER PURIFICATION Osmonics, Inc. FIP Class II 1994-12-29
K942601 PSI FLEXIBLE ARM V. Mueller Neuro/Spine GCJ Class II 1994-12-27
K934348 TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR Tri-Med Specialties, Inc. BSS Class II 1994-12-23
K945527 KARL STORZ TELESCOPE BRIDGES AND ADAPTERS KARL STORZ Endoscopy-America, Inc. FAJ Class II 1994-12-23
K945421 CHAKOFF ENDOSCOPY Stephen Chakoff, Inc. FDG Class I 1994-12-23
K945146 CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE Promex, Inc. FCG Class II 1994-12-21
K945979 TROCAR/CANNULA Endoscopic Technologies, Inc. GCJ Class II 1994-12-21
K944944 CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE Promedical , Ltd. FCG Class II 1994-12-21
K943176 KARL STORZ HOPKINS I&II/OPER/AUTOCLAVABLE TELESCOPESQ KARL STORZ Endoscopy-America, Inc. FAJ Class II 1994-12-21
K944795 KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES KARL STORZ Endoscopy-America, Inc. FAS Class II 1994-12-21
K946023 KARL STORZ TELESCOPE BRIDGES AND ADAPTERS KARL STORZ Endoscopy-America, Inc. GCJ Class II 1994-12-20
K945297 INFRA VISION IMAGING SYSTEM Gabriel Medical, Inc. GCJ Class II 1994-12-20
K943476 GIP/MEDI-GLOBE GOREIGN BODY GRASPERS Medi-Globe Corp. OCZ Class II 1994-12-15
K945970 INSUFFLATOR FILTER TUBING SET Xylog Corp. FCX Class II 1994-12-15
K945751 KARL STORZ TROCARD, FLEXIBLE TROCAR SLEEVES KARL STORZ Endoscopy-America, Inc. GCJ Class II 1994-12-15
K942168 WGL ENDOSCOPIC GRASPER Wilson Greatbatch Technologies, Inc. GCJ Class II 1994-12-13
K945263 OPTUS THORACOSCOPES Optus, Inc. GCJ Class II 1994-12-13
K944607 MODEL 5135 AUTO LP/FLASH Richard Wolf Medical Instruments Corp. GCT Class II 1994-12-13
K945573 BIOPSY DEVICE ACCESSORY Biopsys Medical, Inc. KNW Class II 1994-12-09
K944290 CATHETERS, BILIARY CATHETERS, UROLOGICAL Boston Scientific Corp FFA Class II 1994-12-08
K930731 SLIP-COAT STENTS Cook Urological, Inc. FAD Class II 1994-12-08
K944067 PEANUT WAND, MODIFICATION Ideal Medical, Inc. GCS Class II 1994-12-08
K945420 CHAKOFF ENDOSCOPY Stephen Chakoff, Inc. FCW Class II 1994-12-08
K944299 KARL STORZ INSULATED BIOPSY FORCEPS KARL STORZ Endoscopy-America, Inc. GCJ Class II 1994-12-08
K945637 R-MED MOTORIZED LAPAROSCOPIC HANDLE R-Med, Inc. GCJ Class II 1994-12-07
K944382 ORION ALL SILICONE FOLEY CATHETER Regulatory & Marketing Services, Inc. EZL Class II 1994-12-06
K944383 ORION RED URETHRAL CATHETER Regulatory & Marketing Services, Inc. EZD Class II 1994-12-06
K944377 ORION'S URINARY DRAINAGE SET Regulatory & Marketing Services, Inc. KNX Class II 1994-12-06
K944672 INSURG LAPTIE NEEDLE DRIVER SUTURING DEVICES Boston Scientific Corp GCJ Class II 1994-12-06
K924646 OVER THE GUIDEWIRE DILATATION SYSTEM Medovations, Inc. KNQ Class II 1994-12-05
K945474 SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDER Scanlan Intl., Inc. GCJ Class II 1994-12-05
K944252 BIOPSY DEVICE ACCESSORY Biopsys Medical, Inc. FCK Class II 1994-12-05
K944303 COOK UROLOGICAL LAPAROSCOPIC TROCAR CLEANER Cook Urological, Inc. GCJ Class II 1994-12-02
K944254 OKTAS STEREO VIEWING SYSTEM Oktas FET Class II 1994-11-30
K944380 ORION FOLEY CATHETER Regulatory & Marketing Services, Inc. EZL Class II 1994-11-30
K941488 DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER Medical Technology Development Corp. EZL Class II 1994-11-30
K942338 OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES Olympus Corp. FDT Class II 1994-11-30
K944381 ORION ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE Regulatory & Marketing Services, Inc. EZL Class II 1994-11-30
K944376 ORION ALL SILICONE ELASTOMER COATED CATHETER Regulatory & Marketing Services, Inc. EZL Class II 1994-11-30
K944201 HI-Q HAND INSTRUMENTS- UROLOGY Olympus America, Inc. GCJ Class II 1994-11-29
K933845 WILSON-COOK BALLOON INFLATION DEVICE Wilson-Cook Medical, Inc. KNQ Class II 1994-11-29
K945457 TROCAR ( ACCESORY) United States Surgical, A Division of Tyco Healthc GCJ Class II 1994-11-28
K944415 ORIGIN TACKER SYSTEM Origin Medsystems, Inc. OCW Class II 1994-11-28
K940661 STIEGMANN-GOFF ENDOSCOPIC LIGATOR C.R. Bard, Inc. MND Class II 1994-11-28
K942005 GIP/MED-GLOBE STONE EXTRACTOR BASKETS Medi-Globe Corp. LQR Class II 1994-11-22

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