meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
44
Latest Decision
1999-06-04

Clearances · page 54 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K983220 STRYKER INFRAVISION ESOPHAGEAL KIT Stryker Endoscopy FAT Class II 1999-06-04
K983296 AUTO SUTURE ABBI SYSTEM United States Surgical, A Division of Tyco Healthc KNW Class II 1999-06-04
K984600 METRA PS PROCEDURE KIT Inlet Medical, Inc. GCJ Class II 1999-06-03
K990850 COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL CooperSurgical, Inc. KNS Class II 1999-06-01
K990663 INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150 Medtech , Ltd. GCJ Class II 1999-05-27
K991703 STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM Stryker Instruments GCJ Class II 1999-05-27
K991635 MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER Computer Motion, Inc. GCJ Class II 1999-05-27
K991431 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT Arrow Intl., Inc. MPB Class II 1999-05-26
K990839 TRU-CORE I REUSABLE BIOPSY INSTRUMENT Medical Device Technologies, Inc. KNW Class II 1999-05-20
K990635 VISTA STEREOSCOPE SYSTEM Vista Medical Technologies, Inc. GCJ Class II 1999-05-19
K990645 GALLINI ATRA-CUT NEEDLE Gallini U.S., LLC KNW Class II 1999-05-19
K990894 ETB TROCAR SYSTEM The Altomec Corp. GCJ Class II 1999-05-19
K990731 EASTGATE PERSONAL MONITOR Eastgate Trading Corp. GCJ Class II 1999-05-19
K990493 INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE Innerdyne, Inc. GCJ Class II 1999-05-18
K984022 PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT Arrow Intl., Inc. MPB Class II 1999-05-18
K990509 OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818 Implemed, Inc. EZL Class II 1999-05-18
K983665 MANOMETRIC ASSEMBLIES Dentsleeve Pty., Ltd. KLA Class II 1999-05-17
K990935 JACKSON ESOPHAGEAL DILATOR Pilling Weck Surgical KNQ Class II 1999-05-17
K990716 GALLINI BYCUT NEEDLE Gallini U.S., LLC KNW Class II 1999-05-17
K983720 ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO- Asahi Medical Co., Ltd. MSE Class II 1999-05-17
K990515 MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM International Medical Systems KNW Class II 1999-05-13
K990441 INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300 Sandhill Scientific, Inc. FFX Class II 1999-05-12
K990507 ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER Althin Biopharm, Inc. KPO Class II 1999-05-07
K983154 CYSTIC DUCT BALLOON DILATING CATHETER Applied Medical Resources FGE Class II 1999-05-05
K990376 BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME Ballard Medical Products KNS Class II 1999-05-03
K982340 EXTRACORPOREAL BLOOD CIRCUIT Haidylena Medical Egypt FJK Class II 1999-04-30
K991032 GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58 Guidant Corp. FGE Class II 1999-04-30
K984194 HP M2376A DEVICE LINK SYSTEM Hewlett-Packard Co. MQS Class II 1999-04-30
K990631 CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODEL PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC Cordis Corp. FGE Class II 1999-04-30
K983512 WATER TREATMENT SYSTEM FOR HEMODIALYSIS Water Vault, Inc. FIP Class II 1999-04-28
K990782 DAUM NEUROGATE TROCAR Daum GmbH KNW Class II 1999-04-28
K991097 PBN DRAINAGE CATHETER GUIDEWIRES Medical Device Technologies, Inc. KNY Class II 1999-04-23
K990206 SERIM BLOOD LEAK TEST STRIP Serim Research Corp. FJD Class II 1999-04-21
K982413 COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS Gambro Healthcare KDI Class II 1999-04-21
K990775 URETERAL ACCESS SHEATH SET Applied Medical Resources FED Class II 1999-04-21
K990159 DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 Dynamic Technology Corp. FJI Class II 1999-04-19
K990010 ALTHIN MEDICAL AB ALTRACART II Althin Medical AB KPO Class II 1999-04-15
K974236 MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB Medical Components, Inc. MPB Class II 1999-04-15
K982134 DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851 Dynamic Technology Corp. KDI Class II 1999-04-14
K990414 SMITH & NEPHEW HANDPORT SYSTEM Smith & Nephew, Inc. GCJ Class II 1999-04-14
K990231 WILTEK HOT BIOPSY FORCEPS Wiltek Medical, Inc. KGE Class II 1999-04-13
K990863 MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE Ross Product Div. Abbott Laboratories KNT Class II 1999-04-06
K983997 STERICHEK TOTAL CHLORINE TEST KIT Environmental Test Systems, Inc. MSY Class II 1999-04-02
K990188 INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-1 Intuitive Surgical, Inc. GCJ Class II 1999-04-01
K984355 POINT SETTER Mitaka USA, Inc. GCJ Class II 1999-04-01
K990028 ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE Ethicon Endo-Surgery, Inc. GCJ Class II 1999-04-01
K990220 MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM Medi-Globe Corp. FCG Class II 1999-03-31
K990855 COOPERSURGICAL INFRARED COAGULATOR FOR ENT CooperSurgical, Inc. KNS Class II 1999-03-30
K990278 DAUM NEUROCUT NEUROBIOPSYNEEDLE Daum Corp. KNW Class II 1999-03-30
K990050 URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042 Richard Wolf Medical Instruments Corp. FGB Class II 1999-03-26
K982414 GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS Gambro Healthcare KDI Class II 1999-03-26
K990687 HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS Olympus Optical, Co. PKL Class II 1999-03-26
K990072 BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C Cook Urological, Inc. EZN Class II 1999-03-25
K990145 WILSON-COOK BIPOLAR PROBE Wilson-Cook Medical, Inc. KNS Class II 1999-03-25
K990456 ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP Hollister, Inc. KPI Class II 1999-03-25
K990691 HERMES OPERATING ROOM CONTROL CENTER Computer Motion, Inc. GCJ Class II 1999-03-23
K990334 KSEA ENDOSCOPE HOLDER KARL STORZ Endoscopy-America, Inc. OCV Class II 1999-03-22
K990389 MOSS GASTROSTOMY TUBE Moss Tubes, Inc. KNT Class II 1999-03-22
K983624 GILTECH PLUS CONNECTING TUBE SET Giltech Plus, Inc. KDH Class II 1999-03-18
K984434 MEDIVISION LAPAROSCOPE Medivision Scope Service Center, Inc. GCJ Class II 1999-03-17
K984628 MODIFICATION OF MOSS P.E.G. TRAY Moss Tubes, Inc. KNT Class II 1999-03-17
K990765 FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO Flexmedics OCY Class II 1999-03-15
K983126 FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS Minntech Corp. FIP Class II 1999-03-08
K984607 PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX Richard Wolf Medical Instruments Corp. FBP Class II 1999-03-05
K983164 RESTORE (AKA RE/STOR) Nebl, Inc. MNG Class I 1999-03-05
K990379 MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES Dexide, Inc. GCJ Class II 1999-03-04
K983075 GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28, 1002949-38 Guidant Corp. FGE Class II 1999-03-03
K984629 MOSS TUBES, INC. NASAL TUBE - MARK IV Moss Tubes, Inc. BSS Class II 1999-03-02
K983476 BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES Navion Biomedical Corp. KNT Class II 1999-03-01
K981125 MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6 Medical Components, Inc. MSD Class II 1999-02-26
K984310 MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE Moss Tubes, Inc. KNT Class II 1999-02-24
K990006 ERCO-VAC -C Ercons, Inc. LKY Class II 1999-02-24
K990008 ERCO-RIBBON -C Ercons, Inc. LKY Class II 1999-02-24
K980386 HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0) Gambro Healthcare KDI Class II 1999-02-24
K984136 BARDEX LUBRI-SIL I.C. FOLEY CATHETER Bard Medical Div. MJC Class II 1999-02-16
K990130 WILSON-COOK PANCREATIC WEDGE STENT Wilson-Cook Medical, Inc. FGE Class II 1999-02-12
K982333 MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY Cook, Inc. MSD Class II 1999-02-12
K983010 SELF CATH SET/SAFETY CATH Rusch Intl. FCM Class II 1999-02-12
K974426 POTENCY TEST STRIPS, INDICATOR TEST STRIPS Reprocessing Products Corp LIF Class II 1999-02-10
K990127 CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE (LPGD) Corpak Medsystems KNT Class II 1999-02-10
K983438 MAX IT Dorea, Inc. LKY Class II 1999-02-08
K983015 VIRILIS PENILE PROSTHESIS Specialty Surgical Products, Inc. FTQ Class II 1999-02-05
K981733 DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111 Medtronic Functional Diagnostics A/S FFX Class II 1999-02-04
K981629 NUTRISAFE ENTERAL FEEDING TUBE Schiff & Co. FPD Class II 1999-02-04
K984084 BARDEX LUBRI-SIL FOLEY CATHETER Bard Medical Div. EZL Class II 1999-02-01
K982346 ANGIODYNAMICS ANGIOSTENT BILIARY STENT SYSTEM AngioDynamics, Inc. FGE Class II 1999-01-29
K982500 CHAIT CECOSTOMY CATHETER Cook, Inc. KNT Class II 1999-01-27
K983527 MICROENDOSCOPE, MINIATURIZED BIOPSY SCOPE Dofi Technologies, Inc. GCJ Class II 1999-01-19
K984255 OLYMPUS HX-20 SERIES LIGATING DEVICE Olympus Corp of America MND Class II 1999-01-12
K984444 INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000 Sandhill Scientific, Inc. FFX Class II 1999-01-11
K983566 3-CHIP VIDEO CAMERA Stryker Endoscopy GCJ Class II 1999-01-11
K983707 JMS DIALYZER PRIMING SET Jms Co., Ltd. KOC Class II 1999-01-08
K983567 IMAGE TECHNOLOGIES STERICAM, COUPLER-DRAPE AND TROVIEW IMAGING SYSTEM Med Images, Inc. GCJ Class II 1999-01-07
K981680 ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS Dayton Water Systems FIP Class II 1998-12-31
K982337 CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER Haidylena Medical Egypt FJI Class II 1998-12-29
K983559 BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR Icu Medical, Inc. FJK Class II 1998-12-24
K983811 UNIPOLAR OPTICAL BIOPSY FORCEPS Olympus Winter & Ibe GmbH KGE Class II 1998-12-24
K983366 TRIP TONOMETRY CATHETER, 16F Datex-Engstrom, Inc. KNT Class II 1998-12-23
K983714 SOLARTEC SOURCE 270, MODEL # 90123 Cogent Light Technologies, Inc. FFS Class II 1998-12-23
K983363 DCI ENDOSCOPE KARL STORZ Endoscopy-America, Inc. GCJ Class II 1998-12-18

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