meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
45
Latest Decision
1999-10-06

Clearances · page 53 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K993064 PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) Gambro Renal Care Products KDI Class II 1999-10-06
K992442 V.T.S., INC. (V.T.-3) Vts, Inc. LKY Class II 1999-10-05
K992141 OLYMPUS WORKING ELEMENT FOR PROBES Olympus Winter & Ibe GmbH FDC Class II 1999-09-29
K990500 KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C The Kendal Co. EZL Class II 1999-09-28
K992594 A-15 HEMODIALYZER Althin Medical AB FJI Class II 1999-09-24
K992250 CORE AUDIBLE TROCAR II Core Dynamics, Inc. GCJ Class II 1999-09-24
K992565 A-18 HEMODIALYZER Althin Medical AB FJI Class II 1999-09-23
K984358 OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597 Olympus America, Inc. FDS Class II 1999-09-17
K992755 CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, CORDIS CRIMPING TOOLS, CORDIS INTRODUCER TUBE Cordis, A Johnson & Johnson Co. FGE Class II 1999-09-15
K992050 LUMENON XENON LIGHT SOURCE Walter Lorenz Surgical, Inc. GCT Class II 1999-09-14
K992540 XENON LIGHT SOURCE PES 1 Laser Optik Systeme GmbH & Co. KG GCT Class II 1999-09-14
K992437 SCHOELLY RIGID ENDOSCOPES Fiber Imaging Technologies, Inc. GCJ Class II 1999-09-14
K992196 BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK) Hemocleanse, Inc. FLD Class II 1999-09-10
K991375 BARD BALLOON INFLATION SYSTEM C.R. Bard, Inc. KNT Class II 1999-09-10
K982926 FRESENIUS BLOOD VOLUME MONITOR Fresenius Medical Care North America KDI Class II 1999-09-03
K992137 UROLOGICAL CATHETER Apogee, Inc. GBM Class II 1999-09-03
K990867 RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18 Advanced Cardiovascular Systems, Inc. FGE Class II 1999-09-02
K992190 CORE POUCH Core Dynamics, Inc. GCJ Class II 1999-09-01
K992535 ENDIUS SUCTION/IRRIGATION INSTRUMENT Endius, Inc. OCX Class II 1999-09-01
K974387 PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE Microwave Medical Systems, Inc. KDJ Class II 1999-09-01
K990592 INTRASTENT II Intratherapeutics, Inc. FGE Class II 1999-09-01
K992569 MEDTRONIC AVE BRIDGE STENT Medtronic Ave, Inc. FGE Class II 1999-08-31
K992483 MEDIFIX INC. Medifix, Inc. FAJ Class II 1999-08-30
K991851 RENACLEAR DIALYZER CLEANING SYSTEM Minntech Corp. LIF Class II 1999-08-30
K990510 JMS APHERESIS NEEDLE Jms Co., Ltd. FIE Class II 1999-08-30
K990470 JMS A. V. FISTULA NEEDLE SET Jms Co., Ltd. FIE Class II 1999-08-30
K990785 TROCAR & TROCAR SLEEVES, LAPAROSCOPES, LAPAROSCOPIC FORCEPS, & LAPAROSCOPIC INSTRUMENTS Jakoubek Medizintechnik GmbH GCJ Class II 1999-08-27
K991847 THERMOFLEX SYSTEM Argomed, Inc. KNS Class II 1999-08-26
K992494 FLEXIFLO ENTERAL FEEDING TUBE Ross Product Div. Abbott Laboratories KNT Class II 1999-08-25
K992181 TRIP TONOMETRY CATHETER, 8F Datex-Ohmeda, Inc. KNT Class II 1999-08-24
K992477 ROTOSNARE Inscope, LLC FDI Class II 1999-08-24
DEN990005 THE 3PM EGG MACHINE 3pm Co., Inc. MYE Class II 1999-08-20
K992541 LAPAROCAM Karl Storz Endoscopy GCJ Class II 1999-08-19
K992324 FUNNEL TROCAR Patton Medical Corp. GCJ Class II 1999-08-19
K992114 KSEA CALCUSPLIT Karl Storz Endoscopy FFK Class II 1999-08-18
K992391 UROSURGE SPIRALFLO URETERAL STENT Urosurge, Inc. FAD Class II 1999-08-18
K992006 NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33 Integra Neurocare, LLC OCV Class II 1999-08-17
K991980 MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD HOLSTER AND CABLES, SOFTWARE PACKAGE, FOOTSWITCH, Ethicon Endo-Surgery, Inc. KNW Class II 1999-08-17
K990724 CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES Conway Stuart Medical, Inc. GCJ Class II 1999-08-13
K984546 BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK Hemocleanse, Inc. FLD Class II 1999-08-13
K991718 OPERATING LAPAROSCOPE, 10-5 MM, ANGELED, OPERATING LAPAROSCOPE 12-7MM, ANGLED, OPERATING LAPAROSCOPE, 10-5,,. OBLIQUE, D Richard Wolf Medical Instruments Corp. GCJ Class II 1999-08-12
K990428 DRAINAGE BAG Remington Medical, Inc. EXF Class II 1999-08-12
K991674 CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODELS PC155BJS, PCI156BJS, PC185BJS, PC186BJS Cordis Corp. FGE Class II 1999-08-12
K992499 GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE Gallini U.S., LLC KNW Class II 1999-08-12
K991623 NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA Nipro Medical Corp. FIE Class II 1999-08-09
K992362 FLEXISCOPE IQ 101 Schoelly Fiberoptic GmbH FET Class II 1999-08-05
K991426 MAHE INSTRUMENTS Mahe Intl., Inc. FDC Class II 1999-08-05
K990041 UROSTYM BIOFEEDBACK AND STIMULATION PROBES Laborie Medical Tech Corp. KPI Class II 1999-08-05
K991594 CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS Sangstat Medical Corp. MSB Class II 1999-08-05
K983618 DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE Rockwell Medical Technologies, Inc. KPO Class II 1999-08-05
K992275 FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS Fresenius USA, Inc. KDI Class II 1999-08-04
K991929 INTRASTENT Intratherapeutics, Inc. FGE Class II 1999-08-04
K991028 CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSORIES Cordis Corp. FGE Class II 1999-08-04
K990854 INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE Innerdyne, Inc. FGE Class II 1999-08-02
K992318 MEDTRONIC AVE BRIDGE STENT Medtronic Ave, Inc. FGE Class II 1999-08-02
K992353 BLUNT TIP TROCAR PORT Origin Medsystems, Inc. GCJ Class II 1999-07-30
K991520 FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION Fresenius Medical Care North America KDI Class II 1999-07-30
K992227 CRIT-LINE MONITOR III (CLM III) In-Line Diagnostics Corp. MQS Class II 1999-07-30
K992288 AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE Tyco Intl. (Us), Inc. GCJ Class II 1999-07-30
K991512 ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X Asahi Medical Co., Ltd. FJI Class II 1999-07-29
K991533 MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION Peripheral Ave FGE Class II 1999-07-29
K992251 SWISS LITHOCLAST MULTIPURPOSE PROBE Electro Medical Systems SA FFK Class II 1999-07-27
K991668 COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12) Novartis Nutrition Corp. KNT Class II 1999-07-26
K991416 ENDOSCOPIC CAMERA Genzyme Surgical Product (Genzyme Biosurgery) GCJ Class II 1999-07-20
K991382 SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101 Genicon, LC GCJ Class II 1999-07-15
K991389 ANORECTAL MANOMETRY SUITE, MODEL 9032S0201 Medtronic Functional Diagnostics A/S FFX Class II 1999-07-15
K990341 ELECTRO MECHANICAL LITHOTRIPTOR Northgate Technologies, Inc. FFK Class II 1999-07-14
K991500 SMITH & NEPHEW SUTURE LOK Smith & Nephew Endoscopy, Inc. OCW Class II 1999-07-14
K991377 OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER Omnisonics Medical Technologies GCJ Class II 1999-07-12
K982326 MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY Boston Scientific Corp MSD Class II 1999-07-12
K990237 TROCAR SYSTEM ACCORDING TO HASSON Olympus America, Inc. GCJ Class II 1999-07-12
K991303 VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE Vista Medical Technologies, Inc. GCJ Class II 1999-07-12
K991323 SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR Smith & Nephew, Inc. FFS Class II 1999-07-06
K982974 DD URETERAL STENT, INTEGRAL STENT Rusch Intl. FAD Class II 1999-07-02
K991314 COAGULOOP American Medical Systems, Inc. FAS Class II 1999-06-29
K990628 GYRUS ENDOUROLOGY SYSTEM Gyrus Medical , Ltd. KNS Class II 1999-06-29
K991928 MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORS Allegiance Healthcare Corp. GCJ Class II 1999-06-25
K991366 DAUM MRI/CONVENTIONAL BIOPSY KIT Daum GmbH KNW Class II 1999-06-25
K991793 ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM AngioDynamics, Inc. FGE Class II 1999-06-25
K991042 ASH ADVANTAGE PERITONEAL CATHETER Janin Group, Inc. FJS Class II 1999-06-25
K991444 HERMES CONTROL CENTER, WITH CONTROL OF THE AESOP 3000HR (HERMES READY). Computer Motion, Inc. GCJ Class II 1999-06-25
K991171 DCI ENDOSCOPE Karl Storz Endoscopy GCJ Class II 1999-06-23
K991228 DCI ENDOSCOPE Karl Storz Endoscopy GCJ Class II 1999-06-23
K983373 IMPACT BALLOON DILATION CATHETER B. Braun/Mcgaw KNQ Class II 1999-06-22
K991005 VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO, DPC101VS Dayspring Medical, Inc. LLB Class II 1999-06-22
K991219 C-FLEX URETERAL STENTS Applied Medical Resources FAD Class II 1999-06-21
K990996 GENYX MEDICAL INJECTION NEEDLE Genyx Medical, Inc. FBK Class II 1999-06-18
K990953 RENAL LINK Baxter Healthcare Corp KPF Class II 1999-06-18
K990864 SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228 Boston Scientific Corp MND Class II 1999-06-11
K991178 FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253 Richard Wolf Medical Instruments Corp. FGB Class II 1999-06-11
K990852 COOPERSURGICAL INFRARED COAGULATOR CooperSurgical, Inc. KNS Class II 1999-06-11
K980438 11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT Medical Components, Inc. MPB Class II 1999-06-10
K990909 MTP UROPUMP DISPOSABLE TUBING SET Mtp Medical Technical Promotion GmbH LJH Class II 1999-06-09
K990912 MTP EXTRACTION BAG Mtp Medical Technical Promotion GmbH GCJ Class II 1999-06-09
K991003 PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLI Dayspring Medical, Inc. FKY Class II 1999-06-09
K991734 MODIFICATION OF: HERMES OPERATING ROOM CONTROL CENTER Computer Motion, Inc. GCJ Class II 1999-06-09
K983867 FUJI CATHETER, MODEL CTH001 Windy Hill Technology, Inc. KNW Class II 1999-06-09
K983511 SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH Medical Components, Inc. MPB Class II 1999-06-08
K991288 DISTENDER SERIES II BAROSTAT G & J Electronics, Inc. FFX Class II 1999-06-08
K973844 GASTRIC AND RECTAL CATHETERS G & J Electronics, Inc. FFX Class II 1999-06-04

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