meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
42
Latest Decision
1994-02-22

Clearances · page 73 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K914145 DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES Medivators, Inc. FEB Class II 1994-02-22
K925403 BAXTER APD 12' EXTENSION LINE Baxter Healthcare Corp KDJ Class II 1994-02-22
K933619 PD-PAK General Medical Mfg. Co. MLW Class II 1994-02-22
K933345 NOBLES-LAI ENDOSCOPIC/LAPAROSCOPIC Nobles-Lai Engineering, Inc. GCJ Class II 1994-02-22
K931425 SURGICAL PATCH SPREADER General Surgical Innovations GCJ Class II 1994-02-22
K913728 DENVER(R) PERITONEO-SUBCLAVIAN SHUNT Denver Biomedicals, Inc. KPM Class II 1994-02-18
K923139 HEMOCOR HP HEMOCONCENTRATOR SERIES Minntech Corp. KDI Class II 1994-02-18
K923312 HIGH PERMEABILITY DIALYER Minntech Corp. KDI Class II 1994-02-18
K934547 MECTRA TROCAR Mectra Labs, Inc. GCJ Class II 1994-02-18
K934094 STRYKER LAPAROSCOPIC SUCTION IRRIGATOR Stryker Corp. GCJ Class II 1994-02-18
K933405 COGENT LIGHT ILLUMINATOR 10010 XENON LIGHT SOURCE Cogent Light Technologies, Inc. GCT Class II 1994-02-18
K935247 JEDMED COMPACT ENDOSCOPIC BEAMSPLITTER Jedmed Instrument Co. FEA Class I 1994-02-18
K923848 GOOSEN SELF-LUBRICATING CATHETER Goosen Enterprises, Inc. EZD Class II 1994-02-18
K925499 LAPROSCOPIC/ENDOSCOPIC SURGICAL INSTRUMENTS Lapsurg of America GCJ Class II 1994-02-18
K932074 MEDISYSTEMS APHERESIS NEEDLE WITH GUARD Medisystems Corp. FIE Class II 1994-02-18
K934750 YANKAUER WITH CONNECTING TUBING Trinity Laboratories, Inc. GCJ Class II 1994-02-17
K934510 5,6,7,9,10,11,12MM BLUNT-TIP TROCAR OBTUR/THREAD Phx Technologies Corp. GCL Class II 1994-02-17
K934511 5,6,7,9,10,11&12MM BLUNT-TIPPED TROCAR OBTURATORS Phx Technologies Corp. GCJ Class II 1994-02-17
K935086 AUTO SUTURE DISPOSABLE OPTICAL TROCAR United States Surgical, A Division of Tyco Healthc GCJ Class II 1994-02-17
K925261 NUTRICARE ENTERAL FEEDING TUBE Entracare Corp. KNT Class II 1994-02-17
K932540 LAPORASCOPIC SURGICAL INSTRUMENTS /GENERAL USE Advanced Surgical, Inc. GCJ Class II 1994-02-17
K924065 MIC PEG TUBE Medical Innovations Corp. KNT Class II 1994-02-17
K940259 STERILE TROCAR AND 5.7MM SLEEVE Phx Technologies Corp. GCJ Class II 1994-02-17
K932312 FUJINON VIDEO LAPAROSCOPE -- MODIFIED Fujinon, Inc. FET Class II 1994-02-16
K934528 2C LENS FOG REDUCTION & CLEANING DEVICE H & C Chemical, Inc. GCJ Class II 1994-02-16
K931779 EHL PULSE GENERATOR Psi Medical Products, Inc. FFK Class II 1994-02-15
K935382 GRASPERS Mectra Labs, Inc. GCJ Class II 1994-02-15
K915459 FLOWMATE HAND PUMP Psi Medical Products, Inc. KOD Class II 1994-02-15
K940193 SURGICAL RETRACTOR KIT Advanced Surgical, Inc. GCJ Class II 1994-02-15
K930607 GRIPPER Surgical Instrument, Inc. GCJ Class II 1994-02-15
K935293 FLUID ASPIRATION NEEDLE Surgin Surgical Instrumentation, Inc. GCJ Class II 1994-02-15
K934398 ACCU-BEAM TISSUE DRILL & ASPIRATION/INJECTION NEEDLE Transamerican Technologies Intl. GCJ Class II 1994-02-14
K932843 FLEXIBLE VIDEO SIGMOIDOSCOPE SYSTEM W/DISP. SHEATH Vision-Sciences, Inc. FAM Class II 1994-02-14
K935379 UROLOGICAL BALLOON DILATATION CATHETER Boston Scientific Corp EZN Class II 1994-02-14
K920410 EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB Psi Medical Products, Inc. FFK Class II 1994-02-14
K931048 4-SURE NELATON CATHETER Boston Pacific Medical, Inc. EZD Class II 1994-02-14
K931047 4-SURE FEMALE CATHETER Boston Pacific Medical, Inc. EZD Class II 1994-02-14
K933268 CANDELA GUIDEWIRE Candela Laser Corp. NWU Class II 1994-02-10
K934338 INNOVASIVE NON-STERILE LAPAROSCOPY INSTRUMENTS MODIFICATION Innovasive Devices, Inc. GCJ Class II 1994-02-10
K924549 TRI-MED QUICK-STEP(TM) RECTAL TUBE Tri-Med Specialties, Inc. GBT Class II 1994-02-10
K935878 GLASSER SUTURE NEEDLE Advanced Surgical, Inc. GCJ Class II 1994-02-09
K934647 KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION KARL STORZ Endoscopy-America, Inc. FJL Class II 1994-02-09
K933687 R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260 R & D Batteries, Inc. FKX Class II 1994-02-09
K934377 INNERDYNE REMOTE RADIALLY EXPANDING DILATOR REMOTE R.E.D. Interventional Thermodynamics, Inc. FGE Class II 1994-02-07
K934918 EPM-3300 VIDEO PROCESSOR Pentax Precision Instrument Corp. FET Class II 1994-02-07
K934097 I SIGHT 2020 ENDOSCOPIC & SURGICAL VIDEO CAMERA Sharplan Lasers, Inc. GCJ Class II 1994-02-07
K932434 PROXIMATE ARTICULATING LINEAR STAPLER Ethicon Endo-Surgery, Inc. OCW Class II 1994-02-07
K935999 DAVINCI RECONFIGURABLE LAPAROSCOPIC SURGICAL INSTRUMENTS Da Vinci Medical, Inc. GCJ Class II 1994-02-04
K936154 LAPAROSCOPIC TROCAR STARTER SCALPEL Bd Becton Dickinson Vacutainer Systems Preanalytic GCJ Class II 1994-02-04
K932627 CHAKOFF ENDOSCOPY Stephen Chakoff, Inc. GCJ Class II 1994-02-04
K933075 LAPAROSCOPIC RETRACTOR Origin Medsystems, Inc. GCJ Class II 1994-02-03
K932015 TRI-MED INFLATABLE ESOPHAGEAL DILATOR Tri-Med Specialties, Inc. KNQ Class II 1994-02-03
K930180 BIOPSY CUP FORCEPS Surgical Technologies, Inc. GCJ Class II 1994-02-03
K931522 FASCIAL CLOSURE DEVICE Origin Medsystems, Inc. GCJ Class II 1994-02-03
K932796 OWENS TROCAR Owens Industries, Inc. GCJ Class II 1994-02-02
K915490 MEDCOMP PERITONEAL DIALYSIS CATHETERS Medical Components, Inc. FJS Class II 1994-02-02
K933011 MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER Boston Scientific Corp EZN Class II 1994-02-01
K932441 SERIES 8920 TROCAR SYSTEM Richard Wolf Medical Instruments Corp. GCJ Class II 1994-02-01
K935073 NON-INSULATED SCISSORS KARL STORZ Endoscopy-America, Inc. GCJ Class II 1994-01-31
K935709 GENERAL SURGERY PROBE/GENERAL SURGERY PROBE W/DISTAL PERFORATIONS Zimmer Patient Care Division GCJ Class II 1994-01-31
K935762 AUTO SUTURE DISPOSABLE ENDOSCOPIC SUTURE NEEDLE United States Surgical, A Division of Tyco Healthc GCJ Class II 1994-01-31
K932790 THERMAL OPTION Cox Medical Ent., Inc. KGE Class II 1994-01-28
K933067 PROBES,SCISSORS,FORCEPS,GRASPERS,&NEEDLE HOLDERS Medline Industries, Inc. GCJ Class II 1994-01-27
K924608 HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS Boston Scientific Corp FGE Class II 1994-01-26
K934158 5MM CALIBRATED SUCTION CANNULA Phx Technologies Corp. GCJ Class II 1994-01-26
K935423 COOL LIGHT 300 Endosurgical Development Corp. GCT Class II 1994-01-26
K935426 PREPERITONEAL DISTENTION BALLOON SYSTEM Origin Medsystems, Inc. GCJ Class II 1994-01-26
K934157 HYDRO-PROBE Phx Technologies Corp. GCJ Class II 1994-01-26
K934077 PHX TECHOLOGIES CORP., 5MM STERILE, DISPOSABLE ENDOSCOPIC KITTNER BLUNT DISSECTING INSTRUMENT Phx Technologies Corp. GCJ Class II 1994-01-25
K935070 GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS KARL STORZ Endoscopy-America, Inc. FCL Class I 1994-01-25
K934165 STERILE, DISPOSABLE ENDO SPECIEMEN RETRIEVAL BAG Phx Technologies Corp. GCJ Class II 1994-01-25
K933725 ENDOSCOPIC NEEDLE DRIVER United States Surgical, A Division of Tyco Healthc GCJ Class II 1994-01-25
K925210 90DX MULTITEST METER, MODIFICATION Mesa Medical, Inc. FLB Class II 1994-01-25
K933025 LAPORASCOPIC CANNULA SEAL Li Medical Technologies, Inc. GCJ Class II 1994-01-25
K935250 ACCU-PATH Cox Medical Ent., Inc. FCL Class I 1994-01-21
K934347 ANTIFOG Norpak Mfg., Inc. GCJ Class II 1994-01-21
K934696 ANGIOSCOPE Intramed Laboratories, Inc. LYK Class II 1994-01-18
K925978 MPC-80 TRANSDUCER Molded Products, Inc. FIB Class II 1994-01-14
K931120 COAXIAL ACUTE CATHETER Akcess Medical Products, Inc. LFJ Class II 1994-01-14
K920634 SPLITTABLE SHEATH INTRODUCER SET Akcess Medical Products, Inc. LFJ Class II 1994-01-14
K934279 PHX TECHNOLOGIES CORP., 5MM, 10MM, AND 12MM BLUNT-TIPPED TROCAR OBTURATORS AND MATCHED TROCAR TUBES Phx Technologies Corp. GCJ Class II 1994-01-13
K934280 PHX TECHNOLOGIES CORP., 10 MM THORACOSCOPY SCRAPPER DEVICE Phx Technologies Corp. GCJ Class II 1994-01-13
K934730 KARL STORZ ENDOSCOPIC COLD KNIFE BLADES KARL STORZ Endoscopy-America, Inc. EZO Class II 1994-01-11
K933261 GRASPING FORCEPS Surgitek FGO Class II 1994-01-11
K934170 ENDOMEDIX Y-ADAPTER Endomedix OCX Class II 1994-01-11
K932021 ENTREE CANNULA FASCIA ANCHORS Core Dynamics, Inc. FBM Class I 1994-01-11
K933260 HELICAL STONE/FLATWIRE STONE BASKETS Surgitek FFL Class II 1994-01-11
K932346 AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS Aesculap, Inc. GCJ Class II 1994-01-07
K934598 GRASPING FORCEPS OR RETRIEVAL FORCEPS Annex Medical, Inc. FGO Class II 1994-01-07
K934675 METAL URETERAL BASKET STONE DISLODGER Annex Medical, Inc. FFL Class II 1994-01-07
K934356 WILSON-COOK GI ASPIRATION NEEDLE Wilson-Cook Medical, Inc. FCG Class II 1994-01-07
K934052 ALPINE REUSABLE LEG BAGS Sierra Laboratories, Inc. FAQ Class I 1994-01-07
K933790 5MM DISPOSABLE SUCTION-IRRIGATION CANNULA Phx Technologies Corp. GCJ Class II 1994-01-06
K933789 10MM DISPOSABLE, STERILE SUCTION CANNULA Phx Technologies Corp. GCJ Class II 1994-01-06
K921993 ELS AUTOMATIC TUBING CLAMP SYSTEM Rocky Mountain Research, Inc. FIG Class II 1994-01-05
K933369 CUDA PRODUCTS CORP. LIGHTSOURCES Cuda Products Co. FCW Class II 1994-01-03
K933020 MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER Boston Scientific Corp EYB Class II 1994-01-03
K935064 ENDOPATH ENDOSCOPIC LINEAR CUTTER MODIFICATION ETHICON, Inc. OCW Class II 1994-01-03
K922730 LAKE OSTOMY CARE SET Lake Medical Products, Inc. EXB Class I 1993-12-30
K933895 PHX TECHNOLOGIES CORP., GRASPER-RETRACTOR DEVICE Phx Technologies Corp. GCJ Class II 1993-12-29

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