meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
47
Latest Decision
1991-09-19

Clearances · page 81 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K910786 TROCAR (FALLER STYLET) Accurate Surgical Instruments Co. FJS Class II 1991-09-19
K912927 AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE Intl. Medical, Inc. GCJ Class II 1991-09-19
K912097 AUTO SUTURE ENDOSCOPIC FASCIA STAPLER United States Surgical, A Division of Tyco Healthc GCJ Class II 1991-09-19
K904871 MEDI-KLEER North American Marketing Corp. OCT Class II 1991-09-17
K913870 5MM MICROSCISSORS Endovations GCJ Class II 1991-09-16
K912971 INTHERM RADIALLY EXPANDING DILATER Interventional Therapeutics Corp. FGE Class II 1991-09-13
K912407 COX DISPOSABLE CYTOLOGY BRUSHES Cox Medical Ent., Inc. FDX Class II 1991-09-10
K912549 BARD(R) DISPOSABLE BIOPSY FORCEPS C.R. Bard, Inc. FCL Class I 1991-09-10
K912556 DAVIS AND GECK LAPRO-LOOP LIGATURE CARRIER Davis & Geck, Inc. GCJ Class II 1991-09-09
K913172 ENDOSCOPIC DELIVERY SYSTEM Medco Products, Co., Inc. GCJ Class II 1991-09-06
K913679 UNIVERSAL SWIVEL PATCH Bryman Medical KNY Class II 1991-09-05
K912047 WILSON-COOK RUSSELL GASTROSTOMY KIT Wilson-Cook Medical, Inc. KNT Class II 1991-09-05
K911279 DRY TIME Health Sense Intl., Inc. KPN Class II 1991-09-04
K912531 IMD MULTICAM 1000/2000 VIDEO CAMERA SYSTEMS Innovative Medical Devices, Inc. FET Class II 1991-09-04
K913223 STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES Medical Device Inspection Co., Inc. KNX Class II 1991-09-04
K912394 TRANSDUCER PROTECTOR Filtertek, Inc. FIB Class II 1991-08-30
K912159 MAJOR SET-UP TRAY Medical Device Inspection Co., Inc. GCJ Class II 1991-08-29
K911829 ENDOSTAPLE ETHICON, Inc. GCI Class II 1991-08-28
K912836 CANNULA AND TROCAR Oceanside Biomedics GCJ Class II 1991-08-28
K911199 JMS AV FISTULA NEEDLES Jms Co., Ltd. FIE Class II 1991-08-28
K910785 TITANIUM CATHETER EXTENDER Accurate Surgical Instruments Co. FJS Class II 1991-08-22
K912319 DAVIS & GECK CHROMIC & PLAIN GUT LIGATURE CARRIER Davis & Geck, Inc. GCJ Class II 1991-08-22
K900205 DRAINAGE CATHETERS W/A DISSOLVABLE TIP Boston Scientific Corp FGE Class II 1991-08-20
K912903 PERCUTANEOUS RETRACTOR KIT Applied Urology, Inc. GCJ Class II 1991-08-16
K912354 OLYMOUS XLS XENON LIGHT SOURCE Perkinelmer Optoelectronics GCT Class II 1991-08-16
K910190 BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT C.R. Bard, Inc. KNW Class II 1991-08-16
K912443 CANDELA INTRODUCER SHEATH SYSTEM Candela Laser Corp. FDE Class II 1991-08-16
K910846 BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF C.R. Bard, Inc. EZC Class II 1991-08-16
K911125 DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020 Diagnostic Ultrasound Corp. FAP Class II 1991-08-15
K910691 NORTEC URETERAL STENT North American Sterilization & Packaging Co. FAD Class II 1991-08-15
K910787 TITANIUM CONNECTOR (2 PART) Accurate Surgical Instruments Co. FKO Class II 1991-08-15
K911487 LAPAROSCOPIC CHOLANGIOCATH United States Endoscopy Group, Inc. GCA Class II 1991-08-14
K911492 ENDOSCOPIC LIGHT SOURCE United States Endoscopy Group, Inc. GCT Class II 1991-08-14
K911477 LAPAROSCOPIC BASKET FLEXIBLE AND RIGID United States Endoscopy Group, Inc. LQC Class II 1991-08-14
K911485 COLOR VIDEO CAMERA United States Endoscopy Group, Inc. FET Class II 1991-08-14
K912862 MONOSCOPY(TM) BRANK, HOOK DISSECTOR Dexide, Inc. GCJ Class II 1991-08-12
K911658 DIALYSIS TRANDSDUCER PROTECTOR Tico Medical Instruments, Inc. FIB Class II 1991-08-12
K910821 TRANSDUCER PROTECTOR Gelman Sciences, Inc. FIB Class II 1991-08-12
K912736 ERECAID(R) SYSTEM PLUS Osbon Medical Systems, Ltd. LKY Class II 1991-08-12
K912089 MODIFIED SERIES 2100 ENDOSCOPES Medical Laser, Inc. ODF Class II 1991-08-12
K910197 HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS C.R. Bard, Inc. EZC Class II 1991-08-09
K905677 JEJUNO-CATH KIT Health Improvement Assoc. FPD Class II 1991-08-09
K910195 BARD HYDROGEL-COATED FOLEY CATHETERS C.R. Bard, Inc. EZC Class II 1991-08-09
K912132 OPERAND LUBRICATING JELLY General Medical Co. FHX Class II 1991-08-07
K912129 DOBBHOFF(R) BIPOLAR HEMOSTATIC PROBE Biosearch Medical Products, Inc. KNS Class II 1991-08-07
K910382 FLEXIFLO ENTERAL FEEDING TUBE Abbott Laboratories KNT Class II 1991-08-07
K912120 URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE Olympus Corp. FBN Class II 1991-08-07
K910558 TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET Terumo Medical Corp. FJK Class II 1991-08-07
K911129 MMG BILE BAG Medical Technologies of Georgia EXF Class II 1991-08-07
K911105 SUCTION/IRRIGATION DEVICE WITH HYDRO-DISSECTION United States Surgical, A Division of Tyco Healthc GCJ Class II 1991-08-07
K911603 HEMOSPAL KIT B22 C.G.H. Medical, Inc. KDI Class II 1991-08-07
K911155 OVAL CUP BIOPSY FORCEP Endovations FCF Class II 1991-08-07
K910917 CATHLAB SILICONE BILIARY BALLOON CATHETER Cathlab Corp. GCA Class II 1991-08-02
K912750 MONOSCOPY(TM) BRAND, DUAL SUCTION/IRRIGATION CONTR Dexide, Inc. GCJ Class II 1991-08-02
K913104 MONOSCOPY(TM) BRAND, ELECTROSURGICAL RAKE Dexide, Inc. GCJ Class II 1991-07-31
K911090 OMEGA ANGIOSCOPES (OMEGASCOPES) Omega Universal Technologies, Ltd. LYK Class II 1991-07-31
K911744 PRECISION OPTICS CORPORATION LAPAROSCOPE Precise Optics GCJ Class II 1991-07-26
K912579 THE VOSS DISPOSABLE SUCTION/IRRIGATION CANNULA Voss Products GCJ Class II 1991-07-26
K912146 URETERAL CATHETER HOLDER Inman Liebelt Corp. KNY Class II 1991-07-26
K911788 ECONOVAGE R Autovage KDH Class II 1991-07-26
K912254 COX DIAPOSABLE POLYPECTOMY SNARE Cox Medical Ent., Inc. FDI Class II 1991-07-26
K911919 MINIVAGE(R) Autovage KDH Class II 1991-07-26
K912980 MONOSCOPY BRAND 5MM LOCK TROCAR SLEEVE, MODIFIED Dexide, Inc. GCJ Class II 1991-07-26
K912502 LAPAROSCOPIC LASER FIBER DIVERTER United States Endoscopy Group, Inc. GCJ Class II 1991-07-25
K911897 GASPARAITIS ESOPHAGRAM CATHETER SET E-Z-Em, Inc. KNT Class II 1991-07-24
K912208 FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE Fresenius USA, Inc. KDJ Class II 1991-07-24
K910492 BARD REPLACEMENT GASTROSTOMY TUBE C.R. Bard, Inc. KGC Class II 1991-07-24
K911825 TRIP(TM) NASOGASTRIC SUMP CATHETER Tonometrics, Inc. FFT Class I 1991-07-23
K911813 ENTREE CANNULA Core Dynamics, Inc. FBM Class I 1991-07-19
K911459 GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING Fresenius USA, Inc. KPO Class II 1991-07-17
K911278 OLYMPUS AF ANGIOSCOPE SYSTEM Olympus Corp. LYK Class II 1991-07-17
K911754 SCISSORS,GRASPERS,FORCEPS American Cynamid Co. GCJ Class II 1991-07-17
K910081 TBD Empi KPI Class II 1991-07-15
K912605 AMCATH DISPOSABLE MICRO SCISSORS Intl. Medical, Inc. GCJ Class II 1991-07-11
K911648 REDFIELD INFRARED COAGULATOR Redfield Corp. KNS Class II 1991-07-11
K911600 ILCO INFRARED LIGHT COAGULATOR Holl Meditronics, Inc. KNS Class II 1991-07-09
K903835 ACETATE-FREE DIALYSLATE SOLUTION Physio, Inc. KPO Class II 1991-07-05
K911149 PAL (PROBE FOR ASPIRATION AND LAVAGE) Marlo Surgical Technology GCJ Class II 1991-07-05
K911164 REICH SUCTION/IRRIGATION CANNULA Marlo Surgical Technology GCJ Class II 1991-07-05
K911589 DISPOSABLE SURGICAL TROCAR WITH SEAL Applied Vascular Devices, Inc. GCJ Class II 1991-07-05
K910985 SINGLE-USE LAPAROSCOPIC SUCTION/IRRIGATION CANNULA Precision Laser Products, Inc. GCJ Class II 1991-07-05
K911494 NEEDLE CANNULA United States Endoscopy Group, Inc. GCJ Class II 1991-07-02
K911490 LAPAROSCOPE SUPPORT ARM United States Endoscopy Group, Inc. GCJ Class II 1991-07-02
K911489 PALPATATION AND MEASURING STICK United States Endoscopy Group, Inc. GCJ Class II 1991-07-02
K911700 MONOPOLAR POLLYPECTOMY SNARE Everest Medical Corp. KNS Class II 1991-07-01
K911629 SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%) Serim Research Corp. LIF Class II 1991-06-27
K911628 SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%) Serim Research Corp. LIF Class II 1991-06-27
K910769 SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM Surgitek Medical Engineering Corp. ODD Class II 1991-06-25
K911324 IRRIGATION/ASPIRATION TUBING SET Biomedical Dynamics, Inc. KDH Class II 1991-06-24
K910910 MOSS- ANCHOR SET Moss Medical Products KNT Class II 1991-06-24
K905083 4.5F IMAGECATH ANGIOSCOPE Baxter Healthcare Corp LYK Class II 1991-06-21
K912601 BIPROBE(TM) C.R. Bard, Inc. KNS Class II 1991-06-20
K911480 FLEXIBLE CHOLEDOCHOSCOPE United States Endoscopy Group, Inc. FBN Class II 1991-06-20
K910734 MEDISYSTEMS HEMODIALYSIS FISTULA SET Medisystems Corp. FIE Class II 1991-06-20
K911635 MEADOX(R) SURGIMED(R) BIOPSY GUN II Meadox Surgimed, Inc. KNW Class II 1991-06-20
K905573 XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A Zeon Medical Corp. BSS Class II 1991-06-19
K911243 CHOLANGIOCATH AND ATRAUMATIC BOWEL CLAMP Northgate Technologies, Inc. GCJ Class II 1991-06-19
K905154 GASTROSCAN Medics Instrument Corp. FFX Class II 1991-06-19
K912343 DISTENDABLE PALPATION PROBE Dexide, Inc. GCJ Class II 1991-06-18
K904573 PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA Pentax Precision Instrument Corp. ODG Class II 1991-06-12

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