meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
33
Latest Decision
1995-11-14

Clearances · page 64 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K952932 THE TULIP COMPANY BRANSON #1 ELEVATOR The Tulip Mfg. Co. GCJ Class II 1995-11-14
K952901 THE TULIP COMPANY BRANSON #1 & #2 ELEVATOR The Tulip Mfg. Co. GCJ Class II 1995-11-14
K952953 THE TULIP CXOMPANY BRANSON #2 ELEVATOR The Tulip Mfg. Co. GCJ Class II 1995-11-14
K952902 THE TULIP COMPANY BRANSON POSTERIOR DISSECTOR The Tulip Mfg. Co. GCJ Class II 1995-11-14
K952958 THE TULIP COMPANY BRANSON OVERSHEATH The Tulip Mfg. Co. GCJ Class II 1995-11-14
K954734 THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM (MODIFICATION) The Tulip Mfg. Co. FET Class II 1995-11-14
K952951 THE TULIP COMPANY BRASON NERVE HOOK & DISSECTOR The Tulip Mfg. Co. GCJ Class II 1995-11-14
K954175 DUO BALLOON SYSTEM (DBS) 1[10 AND 12 MM SIZES] Origin Medsystems, Inc. GCJ Class II 1995-11-09
K954174 DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES] Origin Medsystems, Inc. GCJ Class II 1995-11-09
K954116 SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP Technical Products, Inc. FEW Class II 1995-11-06
K953438 SURGICAL INTEGRATED CAMERA SYSTEM Envision Medical Corp. GCJ Class II 1995-11-06
K953286 FCP-9P, FIBER CHOLEDOCHOSCOPE Pentax Precision Instrument Corp. FBN Class II 1995-11-03
K954218 STERILE FEEDING TUBE Baxter Healthcare Corp FPD Class II 1995-11-03
K954089 ENDOPATH OPEN OR ENDOSCOPIC ELECTROSUGICAL COAGULATION & CUTTING DEVICE Ethicon Endo-Surgery, Inc. GCJ Class II 1995-11-02
K936311 MITEK MINI ANCHOR Mitek Surgical Products, Inc. MNV Class II 1995-10-31
K954752 PEDIATRIC EUROPHYLIC FOLEY CATHETER Regulatory & Marketing Services, Inc. EZL Class II 1995-10-30
K952900 THE TULIP COMPANY BRANSON SOFT TISSUE RETRACTOR The Tulip Mfg. Co. GCJ Class II 1995-10-30
K952956 THE TULIP COMPANY BRANSON DOUBLE-ENDED DISSECTOR The Tulip Mfg. Co. GCJ Class II 1995-10-30
K952934 THE TULIP COMPANY BRANSON RECURVED DISSECTOR The Tulip Mfg. Co. GCJ Class II 1995-10-30
K953399 NEEDLE OR CUTTER Biophysic Medical, Inc. KNW Class II 1995-10-30
K952957 THE TULIP INSULATED GRASPERS The Tulip Mfg. Co. GCJ Class II 1995-10-30
K952899 THE TULIP INSULATED SCISSORS The Tulip Mfg. Co. GCJ Class II 1995-10-30
K952955 THE TULIP COMPANY BRANSON STRAIGHT DISSECTOR The Tulip Mfg. Co. GCJ Class II 1995-10-30
K952936 THE TULIP COMPANY BRANSON ANTERIOR ELEVATOR The Tulip Mfg. Co. GCJ Class II 1995-10-30
K952954 THE TULIP COMPANY WEIL-BLAKESLEY FORCEPS The Tulip Mfg. Co. GCJ Class II 1995-10-30
K953640 DUNA II PENILE PROSTHESIS Dacomed Corp. FAE Class II 1995-10-27
K954072 MICROSURGE PUNCTURE CLOSE DEVICE Microsurge, Inc. GCJ Class II 1995-10-26
K954377 FORCEPS, GRASPING, FLEXIBLE ENDOSCOPIC Annex Medical, Inc. FFL Class II 1995-10-26
K941599 MITEK ABSORBABLE ANCHOR Mitek Surgical Products, Inc. MNV Class II 1995-10-24
K953377 DISTENTION BALLOON Origin Medsystems, Inc. GCJ Class II 1995-10-23
K952482 KSEA REVERSE VIDEO KARL STORZ Endoscopy-America, Inc. FET Class II 1995-10-23
K954693 MEHTA BRONCHIAL BIOSPY DRILL United States Endoscopy Group, Inc. FCK Class II 1995-10-23
K953903 LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM Core Dynamics, Inc. GCJ Class II 1995-10-20
K954561 XENON NOPPVA KARL STORZ Endoscopy-America, Inc. GCT Class II 1995-10-19
K951627 INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEM Infinitech, Inc. MPA Class II 1995-10-19
K954341 URODYNAMICS TUBING AND INFUSION SETS Life-Tech Intl., Inc. FEN Class II 1995-10-17
K954108 MODIFIED VERSAPORT United States Surgical, A Division of Tyco Healthc GCJ Class II 1995-10-17
K930530 INCARE PRS 9300 PELVIC FL THERA SYST/TREAT URI INC Hollister, Inc. KPI Class II 1995-10-17
K953691 MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING Meadox Medicals, Div. Boston Scientific Corp. EZN Class II 1995-10-16
K953409 LAPAROSCOPIC TROCAR Core Dynamics, Inc. GCJ Class II 1995-10-16
K953655 J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS Johnson & Johnson Medical, Inc. OCX Class II 1995-10-13
K941279 LOWER BOWEL EVACUATION SYSTEM Tiller Mind Body, Inc. KPL Class II 1995-10-12
K945618 GASTROINTESTINAL TUBES & ACCESSORIES Applied Medical Technologies KNT Class II 1995-10-12
K953332 MS CLASSIQUE BALLOON DILATATION CAHTETER Meadox Medicals, Div. Boston Scientific Corp. FGE Class II 1995-10-07
K954121 CYTOLOGY BRUSH Lighthouse Medical, Inc. FDX Class II 1995-10-07
K953597 NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER Meadox Medicals, Div. Boston Scientific Corp. EZN Class II 1995-10-07
K954596 PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM Promedical , Ltd. FCG Class II 1995-10-07
K953418 ELECTROCAUTERY SHROUD I.C Medical, Inc. GCJ Class II 1995-10-07
K945850 BRAUN DIACAN(R) FISTULA NEEDLES B. Braun of America, Inc. FIE Class II 1995-10-06
K953451 UROPUMP TUBE & DAMPING CHAMGER Life-Tech Intl., Inc. FEN Class II 1995-10-05
K952982 ALTREX 110 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl KDI Class II 1995-10-05
K952983 ALTR NOVA 110 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl KDI Class II 1995-10-05
K952978 ALTRA FLUX 110 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl KDI Class II 1995-10-05
K951646 3DSEE Intl. Telepresence Corp. GCJ Class II 1995-10-04
K946136 INFINITECH LIGHTED INFUSION CANNULA Surgical Technologies, Inc. MPA Class II 1995-10-02
K954278 BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005 Beta Medical Products, Inc. MMZ Class II 1995-10-02
K953121 MICROSURGE THORACOSCOPIC ACCESS SYSTEM Microsurge, Inc. GCJ Class II 1995-09-29
K943361 NORTHGATE FLOW ASSIST TUBING FOR UROLOGY Northgate Technologies, Inc. LJH Class II 1995-09-29
K952980 THE TULIP LARGE SOFT TISSUE RETRACTOR The Tulip Mfg. Co. GCJ Class II 1995-09-29
K954265 TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER NEEDLE Promex, Inc. KNW Class II 1995-09-29
K952935 THE TULIP SMALL SOFT TISSUE RETRACTOR The Tulip Mfg. Co. GCJ Class II 1995-09-29
K953410 BRIMFIELD PRECISION ARTICULATING FAN RETRACTOR Springfield Surgical Instruments GCJ Class II 1995-09-29
K941228 ENDOLUMINAL ACCESS TUBE Med Institute, Inc. KNT Class II 1995-09-27
K951260 URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT Biosearch Medical Products, Inc. KOD Class II 1995-09-27
K923691 TWIN SILICONE CATHETER Medical Components, Inc. MPB Class II 1995-09-25
K954231 AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT Promex, Inc. FCG Class II 1995-09-22
K952965 THE TULIP J DISSECTOR The Tulip Mfg. Co. GCJ Class II 1995-09-22
K953086 WOODBINE/SOLOS, HIGH RESOLUTION 3-CHIP SURGICAL CAMERA Woodbine Optical Corp. GCJ Class II 1995-09-22
K953924 XLS-300 XENON LIGHT SOURCE Specialties of Surgery GCT Class II 1995-09-21
K953951 WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR Wilson-Cook Medical, Inc. GCA Class II 1995-09-19
K952342 GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS Cobe Renal Care, Inc. KDI Class II 1995-09-15
K953611 DEXIDE ENDO-LUBE KIT Dexide, Inc. GCJ Class II 1995-09-15
K954151 BIOACCESS BONE BIOPSY SYSTEM Bioaccess, Inc. KNW Class II 1995-09-15
K951482 ENDOSCOPES, FIBER OPTIC LAPAROSCOPES, (STERILIZABLE) Micro-Medical Devices, Inc. GCJ Class II 1995-09-14
K953783 CONVEEN LEG BAG STRAP Coloplast Corp. FAQ Class I 1995-09-13
K953004 DILATATION CATHETER, BALLOON Boston Scientific Corp EZN Class II 1995-09-13
K953348 ARTICULATING RETRACTOR TISSUE RETRACTORS Gm Engineering, Inc. GCJ Class II 1995-09-12
K953376 ACCESS POINT Access Surgical Intl., Inc. GCJ Class II 1995-09-12
K954155 GREENE, TURNER, MENGHINI STYLE ASPIRATION BIOPSY NEEDLE Promex, Inc. FCG Class II 1995-09-12
K945498 INSTENT ENDOCOIL-T(TM) TRANSHEPATIC BILIARY ENDOPROSTHESIS Instent, Inc. FGE Class II 1995-09-12
K954011 FASCIA CLOSURE DEVICE KARL STORZ Endoscopy-America, Inc. GCJ Class II 1995-09-11
K945747 GAMBRO LUNDIA 94-600 DIALYZER Cobe Renal Care, Inc. KDI Class II 1995-09-08
K924387 INSTENT ENDOCOIL BILIARY ENDOPROSTHESIS Instent, Inc. FGE Class II 1995-09-08
K953923 URESIL INTRODUCING NEEDLE Uresil Corp. KNW Class II 1995-09-08
K953880 BIOPSY NEEDLE Biopsys Medical, Inc. KNW Class II 1995-09-08
K953353 UROVISION JANUS Life-Tech Intl., Inc. FEN Class II 1995-09-08
K953123 QUIK-STITCH Coral Medical, Inc. GCJ Class II 1995-09-08
K950960 REDDY ILLUMINATOR Luxtec Corp. FFS Class II 1995-09-08
K951990 LAPAROSCOPE, ROD-LENS VIEWING AND OPERATING ENDOSCOPE Schoelly Technologies, Inc. GCJ Class II 1995-09-08
K945746 GAMBRO LUNDIA 94-500 DIALYZER Cobe Renal Care, Inc. FJI Class II 1995-09-08
K953375 NG SECURE M.C. Johnson Co., Inc. KNT Class II 1995-09-08
K941801 ANALGRAPH Sandhill Scientific, Inc. KLA Class II 1995-09-08
K953827 GIP/MEDI-GLOBE ERCP CATHETERS Medi-Globe Corp. FGE Class II 1995-09-01
K952580 GAMP & ASSOCIATES DISPOSABLE BARE END FIBER Gamp & Assoc. MPA Class II 1995-09-01
K952586 GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATOR Gamp & Assoc. MPA Class II 1995-09-01
K951996 IMAGYN ENDOSCOPE Imagyn Medical, Inc. GCJ Class II 1995-09-01
K952584 GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICK Gamp & Assoc. MPA Class II 1995-09-01
K953440 ELLMAN LAPTRODE North American Technical Services Corp. GCJ Class II 1995-08-29
K951974 IMAGYN ENDOSCOPE SHEATH Imagyn Medical, Inc. GCJ Class II 1995-08-28
K946140 PRG BUTTON Applied Medical Technologies KNT Class II 1995-08-28

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