meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
49
Latest Decision
1989-02-08

Clearances · page 89 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K883274 SURGITEK (R) UROFLOW SYSTEM Medical Engineering Corp. FFG Class II 1989-02-08
K890315 CAPILLARY FLOW DIALYZERS MODELS CT110G & CT190G Baxter Healthcare Corp KDI Class II 1989-02-08
K885185 INTERA SHIELD AND INTERA UNDERGARMENT Intera Corp. EYQ Class I 1989-02-08
K883111 HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650 Baxter Healthcare Corp FKP Class II 1989-02-08
K890111 GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER Gambro, Inc. FJI Class II 1989-02-08
K860698 THE BOOSTER Knapps Corp. LKY Class II 1989-02-03
K885005 MICROVASIVE GOLD PROBE Boston Scientific Corp KNS Class II 1989-02-01
K885202 16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR Coeur Laboratories, Inc. KOD Class II 1989-01-31
K883748 RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS Kawasumi Laboratories Co., Ltd. FJI Class II 1989-01-31
K884554 PERITONEAL CATHETER STABILIZATION DEVICE 5C4381 Baxter Healthcare Corp FKX Class II 1989-01-31
K885167 TRUDELL BENT CATHETER Sil-Med Corp. FJS Class II 1989-01-31
K882714 URINARY DRAIN BAG, LSL CAT. NO. 1425 AND 1450 Lsl Industries, Inc. EYZ Class I 1989-01-31
K883895 DRIPRIDE ULTRA INCONTINENT PAD Weyerhaeuser Co. EYQ Class I 1989-01-30
K883894 DRIPRIDE PROVIDE SLIM Weyerhaeuser Co. EYQ Class I 1989-01-30
K884725 BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS Baxter Healthcare Corp KPO Class II 1989-01-30
K890218 MICROSURGICAL CYSTOTOME Kinetic Medical Products KOA Class I 1989-01-27
K884609 EURO-COLLINS SOLUTION SETS Fresenius USA, Inc. KDL Class II 1989-01-26
K884900 SIEMENS SECTOR 3.5 AND 5.0 MHZ CDA TRANSDUCER Siemens Medical Solutions USA, Inc. KNW Class II 1989-01-13
K884254 CIRCON ACMI BICAP III THERAPEUTIC SYSTEM Circon Acmi KNS Class II 1989-01-11
K884252 CIRCON ACMI BICAP HEMORRHOID SYSTEM BH-10 & BHP-20 Circon Acmi KNS Class II 1989-01-10
K883469 BARD(R) ASPIRATION BIOPSY SYSTEM C.R. Bard, Inc. KNW Class II 1989-01-06
K884306 BICAP ABLATING FORCEPS BAF-7 Circon Acmi KNS Class II 1989-01-05
K884153 CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE Candela Laser Corp. FGB Class II 1988-12-28
K884154 TRANSLUMINAL ENDARTERECTOMY DEVICE Thomas J. Fogarty, M.D. LIF Class II 1988-12-27
K884275 FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT Abbott Laboratories KNT Class II 1988-12-22
K883068 HEMODIALYSIS CONCENTRATES Dove Medical Supplies KPO Class II 1988-12-22
K883886 DOUBLE CLOSED URINARY DRAINAGE SYSTEM Knight Medical, Inc. FCN Class II 1988-12-19
K883093 TRANSENDOSCOPIC ASPIRATION NEEDLE Endovations FBK Class II 1988-12-08
K884353 ULTRX(TM) 850 ARTIFICIAL KIDNEY Cd Medical, Inc. KDI Class II 1988-12-08
K882878 ODOR-END EMERGENCY CLEAN UP POWDER Cdc Products Corp. EXB Class I 1988-12-08
K884365 MULTIFLOW(TM) 60 KIT Hospal Medical Corp. KDI Class II 1988-12-08
K882531 MODIFIED L.J.'S SEX HELPER L.J. Fant & Co. LKY Class II 1988-12-08
K884243 BLOOD TUBING SET Mediflex Intl. FJK Class II 1988-12-08
K884128 LAKE N/G EXTENSION SET Lake Medical Products, Inc. KNT Class II 1988-12-08
K884309 NH PEDIATRIC REPLACEMENT GASTROSTOMY KIT Biosearch Medical Products, Inc. KNT Class II 1988-12-08
K883592 IMPRA DUAL LUMEN SUBCLAVIAN - FEMORAL CATHETER Impra, Inc. LFJ Class II 1988-12-08
K884326 FILTRAL TM 8 HEMODIALYZER Hospal Medical Corp. KDI Class II 1988-12-05
K883884 PROSTATIC CORE-CUT NEEDLE Euro-Med Intl. KNW Class II 1988-12-05
K884439 GASTROSTOMY FEEDING DEVICE Southside Biotechnology KNT Class II 1988-12-05
K882918 KIM NASO-INTESTINAL TUBE Sheridan Catheter Corp. KNT Class II 1988-12-05
K883319 HILL NASOGASTRIC TUBE Zinetics Medical, Inc. KNT Class II 1988-12-05
K883763 ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH Acme-Monaco Corp. KOD Class II 1988-11-18
K883561 BARD(R) URETERAL STENT W/SUTURE C.R. Bard, Inc. FAD Class II 1988-11-15
K882061 OLYMPUS GF-UM3/EU-M3 Olympus Corp. GDB Class II 1988-11-15
K883768 VAS-CATH CATHETER REPAIR KIT Vas-Cath, Inc. LFJ Class II 1988-11-14
K883787 REUSABLE ADULT INCONTINENT DIAPER Intera Corp. EYQ Class I 1988-11-07
K883393 CAPD DISPOSABLE Y SYSTEM - DY SET Medionics International , Ltd. KDJ Class II 1988-11-03
K882048 MEDITRON ENDOLAV MODEL EL-100 Xylog Corp. KNS Class II 1988-10-31
K883408 NATURALYTE MIXER National Medical Care, Medical Products Div., Inc. FIN Class II 1988-10-31
K882682 COMPAT ENTERAL DELIVERY SYSTEM Sandoz Nutrition KNT Class II 1988-10-28
K883526 PORGES STEPPED NEOPLEX DILATOR Porges Corp. KNQ Class II 1988-10-28
K882428 REDY 2000 Organon Teknika Corp. FKT Class II 1988-10-25
K884061 ADD-A-CATH Femcare , Ltd. KOB Class II 1988-10-25
K883173 MODEL 27084 UROMAT FOR UROLOGICAL IRRIGATION KARL STORZ Endoscopy-America, Inc. OCX Class II 1988-10-25
K883110 BARD URETEROSCOPIC DEVICE C.R. Bard, Inc. FGB Class II 1988-10-21
K883534 CAPILLARY FLOW DIALYZERS MODELS HT.80 & HT.100 Baxter Healthcare Corp FJI Class II 1988-10-21
K881707 INTROCULAR FLUID INJECTOR B&B Medical Assoc., Inc. FIH Class II 1988-10-21
K883644 CAPILLARY FLOW DIALYZERS MODELS HT. 130 & 170 Baxter Healthcare Corp FJI Class II 1988-10-21
K883239 CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS Baxter Healthcare Corp KDJ Class II 1988-10-21
K883234 TONOMITOR (TM) + SUMP Tonometrics, Inc. FFT Class I 1988-10-12
K883610 LAKE FOLEY CATHETERIZATION TRAY Lake Medical Products, Inc. FCN Class II 1988-10-12
K881008 MAXERECT Kenneth Chapman LKY Class II 1988-10-12
K882551 AMBULATORY PH DATA RECORDER SYSTEM, APH-2000 Intl. Biomedics, Inc. KLA Class II 1988-10-12
K883307 CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT Hospal Medical Corp. KDI Class II 1988-10-12
K883589 GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER Gambro, Inc. FJI Class II 1988-09-29
K883374 BARD BIOPSY NEEDLE GUIDANCE DEVICE C.R. Bard, Inc. KNW Class II 1988-09-29
K882418 DRY COMFORT UNDERGARMENT Health Tec, Inc. EYQ Class I 1988-09-29
K883490 ACCUFLO UF CONTROL MODULE NO. 74-0100-3 National Medical Care, Medical Products Div., Inc. FJB Class II 1988-09-29
K883023 MODIFIED ULTRA-FRESH ODOR REDUCING COMPOUND Mentor Corp. GDS Class I 1988-09-29
K883000 ACS ANGIOSCOPE GUIDE WIRE Advanced Cardiovascular Systems, Inc. LYK Class II 1988-09-28
K875108 ACS CORONARY ANGIOSCOPIC CATHETER Advanced Cardiovascular Systems, Inc. LYK Class II 1988-09-27
K882867 CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE Corpak Co. KNT Class II 1988-09-21
K881811 COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS Cobe Laboratories, Inc. FJI Class II 1988-09-15
K870722 LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE National Medical Care, Medical Products Div., Inc. FJK Class II 1988-09-14
K881478 MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS Keymed (Medical & Industrial Equipment), Ltd. KNQ Class II 1988-09-14
K882089 MRM GASTROSTOMY BELT Mrm Products, Inc. KNT Class II 1988-09-13
K883195 FRESENIUS F8 DIALYZER Fresenius USA, Inc. KDI Class II 1988-09-13
K882218 COMPAT (R) ENTERAL DELIVERY SYSTEM Sandoz Nutrition KNT Class II 1988-09-13
K882295 FILLING VOLUME OPTION Eris Medical Technology LJH Class II 1988-09-13
K881469 ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL Baxter Healthcare Corp FER Class II 1988-09-12
K882555 ANOTRON(R) INCONTINENCE CONTROL SYSTEM Biosonics, Inc. KPN Class II 1988-08-30
K881270 GAMBRO MULTIPURPOSE SYSTEM MPS-10 Gambro, Inc. FII Class II 1988-08-24
K883351 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING TUBE Gastrotech, Inc. KNT Class II 1988-08-23
K883336 GASTROSTOMY FEEDING TUBE Gastrotech, Inc. KNT Class II 1988-08-23
K881667 KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH The Kendal Co. GBM Class II 1988-08-12
K882158 MODIFIED TORAY FILTRYZER DIALYZERS Toray Industries (America), Inc. FJI Class II 1988-08-12
K881736 SURGITEK CO2 DELIVERY SYSTEM Medical Engineering Corp. FAP Class II 1988-08-11
K882032 MODEL 90DX MULTITEST METER Mesa Medical, Inc. FLB Class II 1988-08-11
K880581 AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA. Synectics-Dantec FFX Class II 1988-08-11
K881678 SELF ADHESIVE URINARY EXTERNAL CATH. W/REMOVE. TIP Hollister, Inc. KNX Class II 1988-08-11
K880767 MIC NEEDLE JEJUNOSTOMY TUBE KIT Medical Innovations Corp. KNT Class II 1988-08-11
K882130 FOLEY-TEMP(TM) Mallinckroot, Inc. EYB Class II 1988-08-09
K880748 BALL TIP FULGURATING ELECTRODE, 3 FRENCH Cook Urological, Inc. KNS Class II 1988-08-04
K883119 VPI NON-ADHESIVE CONDOM CATHETER Cook Urological, Inc. EYT Class I 1988-08-02
K882157 PANAMEX(TM) URETERAL STENT Kingston Technologies, Inc. FAD Class II 1988-08-02
K883057 COMFORT CATH MALE EXTERNAL CATHETER Sierra Laboratories, Inc. EYT Class I 1988-08-02
K881981 ASSIST(TM) ASEPTIC SYRINGE IRRIGATION SYSTEM Ryder Intl. Corp. KOD Class II 1988-08-02
K881781 CATHETER STRAP Baxter Healthcare Corp KOD Class II 1988-08-02
K881217 GENT-L-KARE STERILE URINARY LEG BAG Geneva Laboratories, Inc. KNX Class II 1988-07-29
K881878 CATHETER WITHDRAWAL UNIT Eris Medical Technology KNY Class II 1988-07-28

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